Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2024-09-09
Clearances · page 11 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241681 | Overjet Image Enhancement Assist | Overjet, Inc. | QIH | Class II | 2024-09-09 |
| K240791 | ADAS 3D | Adas3D Medical S.L. | QIH | Class II | 2024-09-09 |
| K240411 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | QIH | Class II | 2024-09-06 |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | OAS | Class II | 2024-09-06 |
| K233998 | TRAQinform IQ | Aiq Global, Inc. | LLZ | Class II | 2024-09-05 |
| K233977 | Velacur | Sonic Incytes | IYO | Class II | 2024-09-04 |
| K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2024-09-03 |
| K241051 | Vave Wireless Ultrasound System | Vave Health, Inc. | IYN | Class II | 2024-08-30 |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation | OWB | Class II | 2024-08-30 |
| K241847 | Imbio PHA (4.0.0) | Imbio, Inc. | QIH | Class II | 2024-08-30 |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2024-08-30 |
| K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2024-08-30 |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | MUJ | Class II | 2024-08-30 |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | ITX | Class II | 2024-08-30 |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | MYN | Class II | 2024-08-30 |
| K242300 | MI View&GO | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2024-08-30 |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | JAQ | Class II | 2024-08-30 |
| K233826 | Kosmos | EchoNous, Inc. | IYN | Class II | 2024-08-29 |
| K241684 | Overjet Charting Assist | Overjet, Inc. | QIH | Class II | 2024-08-27 |
| K241607 | MyoStrain (6.0) | Myocardial Solutions, Inc. | LNH | Class II | 2024-08-26 |
| K241302 | SonoSync | Samsung Medison Co., Ltd. | LLZ | Class II | 2024-08-23 |
| K241098 | NeuroQuant | Cortechs Labs, Inc. | QIH | Class II | 2024-08-22 |
| K241979 | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) | Beijing Konted Medical Technology Co.,Ltd | IYN | Class II | 2024-08-22 |
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | NFJ | Class II | 2024-08-22 |
| K240290 | AiMIFY (1.x) | Subtle Medical, Inc. | LLZ | Class II | 2024-08-21 |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2024-08-20 |
| K241440 | HealthCCSng | Nano-X AI , Ltd. | JAK | Class II | 2024-08-19 |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC | NQQ | Class II | 2024-08-16 |
| K240740 | qCT LN Quant | Qure.Ai Technologies | QIH | Class II | 2024-08-16 |
| K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2024-08-15 |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | ITX | Class II | 2024-08-15 |
| K241211 | CoLumbo | Smart Soft Healthcare | QIH | Class II | 2024-08-15 |
| K241094 | Bullsai | Turing Medical Technologies, Inc. | LLZ | Class II | 2024-08-13 |
| K241429 | ECHELON Synergy MRI System | Fujifilm Healthcare Corporation | LNH | Class II | 2024-08-13 |
| K242054 | OptimMRI (v2) | Rebrain, Sas | QIH | Class II | 2024-08-12 |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | MOS | Class II | 2024-08-12 |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2024-08-09 |
| K240724 | SynthVISION 1.0.0 | Synthesis Health Intelligence, Inc. | LLZ | Class II | 2024-08-08 |
| K233822 | i2Contour | Mrimath, LLC | QIH | Class II | 2024-08-08 |
| K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | KPS | Class II | 2024-08-08 |
| K233920 | EOSedge | Eos Imaging | KPR | Class II | 2024-08-06 |
| K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | QTZ | Class II | 2024-08-06 |
| K240953 | AI Platform 2.0 (AIP002) | Exo Imaging | QIH | Class II | 2024-08-05 |
| K233761 | Orthopaedic Surgery Planning Software (AIJOINT) | Longwood Valley Medical , Ltd. | LLZ | Class II | 2024-08-05 |
| K242008 | Coronis OneLook | Barco N.V. | PGY | Class II | 2024-08-02 |
| K234141 | AISAP Cardio V1.0 | Aisap | POK | Class II | 2024-08-01 |
| K240301 | MammoScreen® (3) | Therapixel | QDQ | Class II | 2024-08-01 |
| K241105 | 3MP Color LCD Monitor (CL-S301) | Jvckenwood Corporation | PGY | Class II | 2024-08-01 |
| K233731 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | 2024-08-01 |
| K241898 | Symbia SPECT and SPECT/CT Systems | Siemens Healthineers | KPS | Class II | 2024-07-26 |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) | DRTECH Corporation | KPR | Class II | 2024-07-26 |
| K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. | MUI | Class II | 2024-07-24 |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | IYE | Class II | 2024-07-24 |
| K240906 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2024-07-23 |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. | LLZ | Class II | 2024-07-23 |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2024-07-22 |
| K231133 | neo315 | Neoscan Solution GmbH | LNH | Class II | 2024-07-22 |
| K241879 | vRad Viewer | Virtual Radiologic Corporation | LLZ | Class II | 2024-07-18 |
| K241121 | MICSI-RMT | Microstructure Imaging, Inc. | LLZ | Class II | 2024-07-17 |
| K240705 | Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation | LLZ | Class II | 2024-07-17 |
| K240845 | Rayvolve | Azmed Sas | QBS | Class II | 2024-07-17 |
| K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | LNH | Class II | 2024-07-16 |
| K241441 | RadiForce RX670; RadiForce RX670-AR | Eizo Corporation | PGY | Class II | 2024-07-16 |
| K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG | KPS | Class II | 2024-07-15 |
| K241727 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2024-07-12 |
| K241713 | HiRise (1040-230) | Curvebeam, LLC | JAK | Class II | 2024-07-12 |
| K233457 | RUS | Hutom, Inc. | QIH | Class II | 2024-07-12 |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | QIH | Class II | 2024-07-12 |
| K241329 | SubtleSYNTH (1.x) | Subtle Medical, Inc. | QIH | Class II | 2024-07-11 |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | JAQ | Class II | 2024-07-10 |
| K240610 | deepLive | Damae Medical | NQQ | Class II | 2024-07-09 |
| K240009 | iQFlex Pro | First Source, Inc. | IZL | Class II | 2024-07-03 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | ITX | Class II | 2024-07-03 |
| K240736 | SMART Bun-Yo-Matic X-Ray | Disior, Ltd. | QIH | Class II | 2024-07-02 |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | JAQ | Class II | 2024-07-02 |
| K241300 | ViewPoint 6 | Ge Healthcare GmbH | LLZ | Class II | 2024-07-02 |
| K240353 | Hyper Insight - ICH | Sk, Inc. | QAS | Class II | 2024-07-01 |
| K233908 | cNeuro cDAT | Combinostics OY | LLZ | Class II | 2024-07-01 |
| K241608 | nordicMEDiVA | Nordicneurolab AS | LLZ | Class II | 2024-06-28 |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | IYO | Class II | 2024-06-26 |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | JAA | Class II | 2024-06-26 |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Esaote, S.p.A. | LNH | Class II | 2024-06-26 |
| K240582 | VEA Align; spineEOS | Eos Imaging | QIH | Class II | 2024-06-25 |
| K233230 | See Factor CT3 | Epica International, Inc. | OWB | Class II | 2024-06-21 |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2024-06-21 |
| K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc. | OWB | Class II | 2024-06-21 |
| K233196 | Medihub Prostate | JLK, Inc. | QIH | Class II | 2024-06-21 |
| K240642 | SMART Bun-Yo-Matic CT | Disior, Ltd. | QIH | Class II | 2024-06-20 |
| K233331 | MediOMx | Pmx, Inc. | LLZ | Class II | 2024-06-17 |
| K240684 | 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, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2024-06-17 |
| K241083 | SIS System | Surgical Information Sciences, Inc. | QIH | Class II | 2024-06-14 |
| K233955 | Clarius OB AI | Clarius Mobile Health Corp. | IYN | Class II | 2024-06-14 |
| K241499 | 21.3 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp. | PGY | Class II | 2024-06-13 |
| K233662 | Radiography 7300 C | Philips Medical Systems Dmc GmbH | KPR | Class II | 2024-06-13 |
| K233925 | Relu Creator | Relu BV | QIH | Class II | 2024-06-13 |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | 2024-06-12 |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2024-06-12 |
| K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2024-06-12 |
| K234106 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-06-10 |
| K233767 | OmniTom Elite | Neurologica Corporation | JAK | Class II | 2024-06-10 |
14,721 clearances in the Radiology panel. Data: openFDA.