FDA Product Code
FDA Product Code IYN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1550
510(k) Clearances — 1,186 records · page 3 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) | Guangzhou Sonostar Technologies Co., Ltd. | 2022-10-13 | Abbreviated | PDF ↗ |
| K220857 | X-CUBE 50, X-CUBE 60 | Alpinion Medical Systems Co., Ltd. | 2022-10-13 | Traditional | PDF ↗ |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | Bionet Co., Ltd. | 2022-10-11 | Traditional | PDF ↗ |
| K221496 | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 | Traditional | PDF ↗ |
| K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 | Traditional | PDF ↗ |
| K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) | Philips Ultrasound, LLC | 2022-09-27 | Traditional | PDF ↗ |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2022-09-15 | Traditional | PDF ↗ |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2022-09-13 | Traditional | PDF ↗ |
| K221568 | KOLO Evolution XHD Series Ultrasound Diagnostic System | Kolo Medical (Suzhou) Co., Ltd. | 2022-09-12 | Traditional | PDF ↗ |
| K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-08-22 | Traditional | PDF ↗ |
| K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022-08-16 | Traditional | PDF ↗ |
| K220882 | Vivid E80, Vivid E90, Vivid E95 | Ge Medical Systems Ultrasound And | 2022-07-22 | Traditional | PDF ↗ |
| K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-18 | Traditional | PDF ↗ |
| K221148 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2022-07-18 | Traditional | PDF ↗ |
| K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-15 | Traditional | PDF ↗ |
| K213009 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2022-07-08 | Traditional | PDF ↗ |
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K220851 | Venue | GE Medical Systems | 2022-06-27 | Traditional | PDF ↗ |
| K220848 | Venue Fit | GE Medical Systems | 2022-06-27 | Traditional | PDF ↗ |
| K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2022-06-23 | Traditional | PDF ↗ |
| K220800 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-21 | Traditional | PDF ↗ |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-06-17 | Traditional | PDF ↗ |
| K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022-06-14 | Traditional | PDF ↗ |
| K213862 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-06-08 | Traditional | PDF ↗ |
| K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-06 | Traditional | PDF ↗ |
| K211665 | SONON Ultrasound Imaging System, Model: SONON300C | Healcerion Co., Ltd. | 2022-05-16 | Special | PDF ↗ |
| K220446 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-05-11 | Traditional | PDF ↗ |
| K220269 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-05-06 | Traditional | PDF ↗ |
| K220295 | ARIETTA 50 | Fujifilm Healthcare Corporation | 2022-04-29 | Abbreviated | PDF ↗ |
| K212400 | SONON Ultrasound Imaging System, Model: SONON 500L | Healcerion Co., Ltd. | 2022-04-22 | Traditional | PDF ↗ |
| K220490 | ImaCor Zura Handheld ZHH-010 | Imacor, Inc. | 2022-04-08 | Traditional | PDF ↗ |
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022-04-05 | Traditional | PDF ↗ |
| K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-25 | Traditional | PDF ↗ |
| K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-03-22 | Traditional | PDF ↗ |
| K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | 2022-03-22 | Traditional | PDF ↗ |
| K220051 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-04 | Traditional | PDF ↗ |
| K213279 | NovaGuide 2 Intelligent Ultrasound | Novasignal Corporation | 2022-03-02 | Traditional | PDF ↗ |
| K211746 | Pocket Ultrasound System | Guangdong Youkey Medical Co., Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K213689 | Voluson P6, Voluson P8 | GE Healthcare | 2022-02-17 | Traditional | PDF ↗ |
| K213487 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022-02-11 | Traditional | PDF ↗ |
| K211248 | ArtUs | Telemed | 2022-02-11 | Traditional | PDF ↗ |
| K213523 | X-CUBE i8, X-CUBE i9 | Alpinion Medical Systems Co., Ltd. | 2022-01-28 | Traditional | PDF ↗ |
| K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | 2022-01-24 | Traditional | PDF ↗ |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | GE Healthcare | 2022-01-13 | Traditional | PDF ↗ |
| K213102 | ES1 System | E-Scopics | 2022-01-11 | Traditional | PDF ↗ |
| K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021-12-27 | Traditional | PDF ↗ |
| K211886 | Clivia series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-12-02 | Traditional | PDF ↗ |
| K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-16 | Traditional | PDF ↗ |
| K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2021-11-15 | Special | PDF ↗ |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-05 | Traditional | PDF ↗ |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2021-11-03 | Traditional | PDF ↗ |
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | Philips Medical Systems | 2021-09-24 | Traditional | PDF ↗ |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | Esaote, S.p.A. | 2021-09-16 | Traditional | PDF ↗ |
| K210438 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-09-10 | Traditional | PDF ↗ |
| K211488 | LOGIQ E10 | GE Healthcare | 2021-09-10 | Traditional | PDF ↗ |
| K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-09-09 | Traditional | PDF ↗ |
| K211945 | V8 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-09-08 | Traditional | PDF ↗ |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | 2021-09-08 | Traditional | PDF ↗ |
| K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | 2021-08-27 | Traditional | PDF ↗ |
| K211527 | Exo Iris | Exo Imaging, Inc. | 2021-08-20 | Traditional | PDF ↗ |
| K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-19 | Traditional | PDF ↗ |
| K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-18 | Traditional | PDF ↗ |
| K211299 | X-CUBE 70 | Alpinion Medical Systems Co., Ltd. | 2021-08-09 | Traditional | PDF ↗ |
| K211300 | X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | 2021-08-09 | Traditional | PDF ↗ |
| K212100 | Kosmos | EchoNous, Inc. | 2021-08-06 | Traditional | PDF ↗ |
| K210154 | Labat series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-07-30 | Traditional | PDF ↗ |
| K211859 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021-07-20 | Traditional | PDF ↗ |
| K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-07-09 | Traditional | PDF ↗ |
| K211337 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-07-01 | Traditional | PDF ↗ |
| K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 | Supersonic Imagine | 2021-06-29 | Traditional | PDF ↗ |
| K203657 | Vu-Path Ultrasound System | Crystalline Medical | 2021-06-25 | Traditional | PDF ↗ |
| K211232 | Apache Ultrasound System | Aco Healthcare Co., Ltd. | 2021-06-25 | Traditional | PDF ↗ |
| K210959 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-06-24 | Traditional | PDF ↗ |
| K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 | Traditional | PDF ↗ |
| K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 | Traditional | PDF ↗ |
| K211216 | Vivid S60N / Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-06-09 | Traditional | PDF ↗ |
| K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-05-13 | Traditional | PDF ↗ |
| K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021-04-09 | Traditional | PDF ↗ |
| K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2021-04-08 | Traditional | PDF ↗ |
| K210743 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021-04-01 | Traditional | PDF ↗ |
| K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-23 | Traditional | PDF ↗ |
| K202658 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-03-05 | Traditional | PDF ↗ |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2021-03-02 | Traditional | PDF ↗ |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2021-02-26 | Traditional | PDF ↗ |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2021-02-26 | Traditional | PDF ↗ |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2021-02-25 | Traditional | PDF ↗ |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2021-02-25 | Traditional | PDF ↗ |
| K203406 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2021-02-23 | Traditional | PDF ↗ |
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | Viasonix , Ltd. | 2021-01-25 | Traditional | PDF ↗ |
| K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 | Edan Instruments, Inc. | 2021-01-25 | Traditional | PDF ↗ |
| K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-01-08 | Traditional | PDF ↗ |
| K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-12-29 | Traditional | PDF ↗ |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems | Supersonic Imagine | 2020-12-29 | Special | PDF ↗ |
| K202233 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-18 | Traditional | PDF ↗ |
| K202132 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-13 | Traditional | PDF ↗ |
| K202074 | Apache Ultrasound System (Model C62) | Compal Electronics, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-11-09 | Traditional | PDF ↗ |
| K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS | Olympus Medical Systems Corp. | 2020-11-09 | Special | PDF ↗ |
| K202422 | Arietta 65 | Hitachi Healthcare Americas | 2020-11-04 | Traditional | PDF ↗ |
| K202556 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020-10-30 | Traditional | PDF ↗ |
Product code IYN · Class II · Radiology. Data: openFDA.