Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2021-11-10
Clearances · page 23 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K212887 | RTapp | Segana, Inc. | LLZ | Class II | 2021-11-10 |
| K212550 | Hura CTP v1.0 | Hura Imaging, Inc. | LLZ | Class II | 2021-11-08 |
| K212956 | FDR Cross (DR-XD 3000) | Fujifilm Corporation | OWB | Class II | 2021-11-08 |
| K211356 | GIQuant | Motilent, Ltd. | LLZ | Class II | 2021-11-08 |
| K212523 | VFSS Pro Mobile Digital Imaging System | Imagexray, LLC | OWB | Class II | 2021-11-05 |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2021-11-05 |
| K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | 2021-11-05 |
| K212896 | Visible Patient Suite | Visible Patient, Sas | LLZ | Class II | 2021-11-05 |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | IYN | Class II | 2021-11-03 |
| K212515 | MOVIX DReamy | Stephanix | IZL | Class II | 2021-11-03 |
| K203372 | SyMRI | Syntheticmr AB | LNH | Class II | 2021-11-03 |
| K210921 | TaiChiB | Our United Corporation | IYE | Class II | 2021-11-02 |
| K213326 | VisionX 3.0 | Durr Dental SE | LLZ | Class II | 2021-11-02 |
| K211987 | ATEC Alignment App | Alphatec Spine, Inc. | LLZ | Class II | 2021-10-29 |
| K211064 | nView s1 with nav option | Nview Medical | OWB | Class II | 2021-10-29 |
| K213351 | ds Head 32ch 3.0T | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | 2021-10-29 |
| K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | Ge Medical Systems, LLC | QIH | Class II | 2021-10-29 |
| K213081 | CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | IZF | Class II | 2021-10-26 |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | QKB | Class II | 2021-10-25 |
| K210807 | FlightPlan for Liver | GE Medical Systems SCS | LLZ | Class II | 2021-10-22 |
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | OXO | Class II | 2021-10-21 |
| K212470 | iRAD | Claritas Healthtech Pte, Ltd. | LLZ | Class II | 2021-10-20 |
| K210632 | Contour ProtegeAI | Mim Software, Inc. | QKB | Class II | 2021-10-20 |
| K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. | OAS | Class II | 2021-10-19 |
| K212528 | Change Healthcare Cardiology | Change Healthcare Israel , Ltd. | LLZ | Class II | 2021-10-18 |
| K212753 | 0909FCB, 1212FCA | Rayence Co., Ltd. | MQB | Class II | 2021-10-18 |
| K210999 | SwiftMR | Airs Medical, Inc. | LLZ | Class II | 2021-10-14 |
| K202808 | Brainance MD | Advantis Medical Imaging Single Member P.C. | LLZ | Class II | 2021-10-14 |
| K212261 | StrokeSENS LVO | Circle Neurovascular Imaging, Inc. | QAS | Class II | 2021-10-14 |
| K212116 | VBrain-OAR | Vysioneer, Inc. | QKB | Class II | 2021-10-12 |
| K211406 | OASIS MRI System | Hitachi Healthcare Americas | LNH | Class II | 2021-10-07 |
| K211429 | NAVIPLAN - CT Planning Software for Total Hip Replacement | Naviswiss AG | LLZ | Class II | 2021-10-05 |
| K212233 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | LNH | Class II | 2021-10-05 |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | LLZ | Class II | 2021-10-04 |
| K212114 | Elekta Unity | Elekta Solutions AB | IYE | Class II | 2021-10-01 |
| K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2021-10-01 |
| K212794 | Accuray Precision Treatment Planning System | Accuray Incorporated | IYE | Class II | 2021-09-30 |
| K211591 | NAEOTOM Alpha, Scan&GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2021-09-30 |
| K210726 | ImmersiveTouch | Immersivetouch, Inc. | LLZ | Class II | 2021-09-29 |
| K211964 | SubtlePET | Subtle Medical, Inc. | KPS | Class II | 2021-09-28 |
| K211700 | EzDent Web | Ewoosoft Co., Ltd. | LLZ | Class II | 2021-09-28 |
| K211760 | Panther OIS | Prowess, Inc. | IYE | Class II | 2021-09-28 |
| K210894 | SIDDHARTH-II; IMPACT | Panacea Medical Technologies Pvt. , Ltd. | IYE | Class II | 2021-09-28 |
| K212557 | Virtual C DRF-NEO Digital Imaging System | Portavision Medical, LLC | OWB | Class II | 2021-09-24 |
| K212777 | Collaboration Live | Philips Ultrasound, Inc. | LLZ | Class II | 2021-09-24 |
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | Philips Medical Systems | IYN | Class II | 2021-09-24 |
| K212321 | JiveX (Model Number / Release: 5.3) | Visus Health IT GmbH | LLZ | Class II | 2021-09-23 |
| K212303 | T2 | Osstem Implant Co., Ltd. | OAS | Class II | 2021-09-21 |
| K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | JAA | Class II | 2021-09-21 |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | MWP | Class II | 2021-09-20 |
| K212067 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | JAK | Class II | 2021-09-17 |
| K212269 | Intelligent NR | Canon, Inc. | MQB | Class II | 2021-09-17 |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | Esaote, S.p.A. | IYN | Class II | 2021-09-16 |
| K212604 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2021-09-16 |
| K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | JAK | Class II | 2021-09-15 |
| K212606 | BeamSite | Doseoptics, LLC | IYE | Class II | 2021-09-15 |
| K212291 | PHOENIX | Sedecal., Sa. | IZL | Class II | 2021-09-14 |
| K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | NFJ | Class II | 2021-09-13 |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | ITX | Class II | 2021-09-13 |
| K212685 | KONICAMINOLTA DI-X1 | Konica Minolta, Inc. | LLZ | Class II | 2021-09-13 |
| K210438 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2021-09-10 |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | QHA | Class II | 2021-09-10 |
| K211257 | EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai, Co., Ltd. | LLZ | Class II | 2021-09-10 |
| K202056 | Kinepict Medical Imaging Tool 4.0 | Kinepict Health, Ltd. | LLZ | Class II | 2021-09-10 |
| K211488 | LOGIQ E10 | GE Healthcare | IYN | Class II | 2021-09-10 |
| K211828 | Aquilion Exceed LB | Canon Medical Systems Corporation | JAK | Class II | 2021-09-10 |
| K203785 | ClariSIGMAM | Claripi, Inc. | QIH | Class II | 2021-09-10 |
| K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2021-09-09 |
| K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | Canon, Inc. | MQB | Class II | 2021-09-09 |
| K211945 | V8 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2021-09-08 |
| K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2021-09-08 |
| K203555 | AmCAD-UT | Amcad Biomed Corporation | QIH | Class II | 2021-09-08 |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | IYN | Class II | 2021-09-08 |
| K212421 | ADAS 3D | Adas3D Medical S.L. | LLZ | Class II | 2021-09-03 |
| K211881 | AI Segmentation | Varian Medical Systems, Inc. | MUJ | Class II | 2021-09-02 |
| K203722 | RayPilot System | Micropos Medical AB | IYE | Class II | 2021-09-02 |
| K212494 | Lung Image Analysis | Pulmonx Corporation | JAK | Class II | 2021-09-02 |
| K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | MYN | Class II | 2021-08-31 |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | MWP | Class II | 2021-08-31 |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | JAA | Class II | 2021-08-31 |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | MWP | Class II | 2021-08-31 |
| K212383 | EndoNaut | Therenva Sas | OWB | Class II | 2021-08-31 |
| K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2021-08-27 |
| K203696 | RBknee | Radiobotics Aps | LLZ | Class II | 2021-08-27 |
| K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | KPS | Class II | 2021-08-27 |
| K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | IYN | Class II | 2021-08-27 |
| K212051 | RFA-1717DIG, RFA-1717DIC | Astel, Inc. | MQB | Class II | 2021-08-25 |
| K212134 | Diagnostic X-ray System/PLX5200A | Nanjing Perlove Medical Equipment Co., Ltd. | IZL | Class II | 2021-08-25 |
| K210619 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2021-08-24 |
| K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | Pzmedical Technology Co., Ltd. | MQB | Class II | 2021-08-23 |
| K211793 | EzOrtho | Ewoosoft Co., Ltd. | LLZ | Class II | 2021-08-23 |
| K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | LNH | Class II | 2021-08-23 |
| K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2021-08-20 |
| K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | IYE | Class II | 2021-08-20 |
| K211527 | Exo Iris | Exo Imaging, Inc. | IYN | Class II | 2021-08-20 |
| K203486 | Otoplan | Cascination AG | QQE | Class II | 2021-08-20 |
| K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | KPS | Class II | 2021-08-20 |
| 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) | IYN | Class II | 2021-08-19 |
| K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IYN | Class II | 2021-08-18 |
| K210998 | ROSA Hip System | Orthosoft D/B/A Zimmer Cas | LLZ | Class II | 2021-08-17 |
14,721 clearances in the Radiology panel. Data: openFDA.