Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 30
- Latest Decision
- 2024-03-13
Clearances · page 13 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233930 | MRCP+ version 2 (MRCP+ v2) | Perspectum | LLZ | Class II | 2024-03-13 |
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | KPR | Class II | 2024-03-12 |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | MQB | Class II | 2024-03-07 |
| K233692 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-03-07 |
| K231677 | EdgeFlow UH10 | Edgecare, Inc. | IYO | Class II | 2024-03-06 |
| K233572 | Autofuse | Pymedix | LLZ | Class II | 2024-03-06 |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | MYN | Class II | 2024-03-04 |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | NFJ | Class II | 2024-03-01 |
| K233030 | BoneMRI | Mriguidance B.V. | QIH | Class II | 2024-03-01 |
| K231690 | iCAS-LV | Highrad , Ltd. | QIH | Class II | 2024-03-01 |
| K231683 | inHEART Models | Inheart, Sas | QIH | Class II | 2024-02-29 |
| K232765 | MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2024-02-29 |
| K232613 | CT Cardiomegaly | Innolitics, LLC | QIH | Class II | 2024-02-28 |
| K233590 | Overjet Charting Assist | Overjet, Inc. | QIH | Class II | 2024-02-23 |
| K233722 | RADspeed Pro | Shimadzu Corporation | KPR | Class II | 2024-02-23 |
| K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | JAK | Class II | 2024-02-22 |
| K233439 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | IYN | Class II | 2024-02-21 |
| K240146 | BD Prevue II Peripheral Vascular Access System | Bard Access Systems, Inc. | IYO | Class II | 2024-02-18 |
| K233652 | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | MOS | Class II | 2024-02-16 |
| K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2024-02-16 |
| K233656 | Contour Shoulder | Quality Electrodynamics | MOS | Class II | 2024-02-15 |
| K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) | Medisono | IYN | Class II | 2024-02-15 |
| K240157 | InVision 1.5 Surgical Theatre | Deerfield Imaging, Inc. | LNH | Class II | 2024-02-15 |
| K240130 | Medical Monitor (21HQ613D) | Lg Electronics.Inc | PGY | Class II | 2024-02-15 |
| K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | IZL | Class II | 2024-02-14 |
| K231855 | QOCA® image Smart RT Contouring System | Quanta Computer, Inc. | QKB | Class II | 2024-02-13 |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2024-02-13 |
| K232082 | EXPD 4343S | DRTECH Corporation | MQB | Class II | 2024-02-13 |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | IYO | Class II | 2024-02-12 |
| K233217 | Mimics Cardiac Planner | Materialise NV | LLZ | Class II | 2024-02-12 |
| K233080 | HealthFLD | Nano-X AI , Ltd. | JAK | Class II | 2024-02-08 |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | IWB | Class II | 2024-02-08 |
| K232644 | neuro42 MRI System | Neuro42, Inc. | LNH | Class II | 2024-02-08 |
| K231662 | Aid-U | Iaid | LLZ | Class II | 2024-02-08 |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2024-02-06 |
| K240099 | Ziehm Vision RFD | Ziehm Imaging GmbH | OWB | Class II | 2024-02-05 |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | 2024-02-05 |
| K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | QIH | Class II | 2024-02-05 |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | JAQ | Class II | 2024-02-01 |
| K232339 | Augmented Reality Application | Sira Medical, Inc. | LLZ | Class II | 2024-02-01 |
| K232007 | CAAS MR Solutions | Pie Medical Imaging BV | LLZ | Class II | 2024-02-01 |
| K231396 | CEPHX- Cephalometric Analysis Software | Orca Dental AI , Ltd. | LLZ | Class II | 2024-01-31 |
| K240020 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | 2024-01-30 |
| K233394 | Gem Flow Now (GEM2770-FN) | Synovis Micro Companies Alliance | IYN | Class II | 2024-01-28 |
| K234109 | Ziehm Solo FD | Ziehm Imaging GmbH | OWB | Class II | 2024-01-26 |
| K233714 | BreView | GE Medical Systems SCS | LLZ | Class II | 2024-01-25 |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2024-01-24 |
| K231607 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | LLZ | Class II | 2024-01-24 |
| K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | POK | Class II | 2024-01-19 |
| K233728 | SIGNA Champion | Ge Healthcare (Tianjin) Company Limited | LNH | Class II | 2024-01-19 |
| K232698 | NemoScan | Software Nemotec S.L. | QIH | Class II | 2024-01-18 |
| K231762 | uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2024-01-18 |
| K231573 | ThinkQA (Edition 2) | Dosisoft SA | IYE | Class II | 2024-01-18 |
| K234030 | Clear Guide SCENERGY | Clear Guide Medical | JAK | Class II | 2024-01-17 |
| K231871 | Radify Triage | Envisionit Deepai, Ltd. | QFM | Class II | 2024-01-17 |
| K233226 | FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC | LLZ | Class II | 2024-01-17 |
| K223234 | Delta4 Insight | Scandidos AB | IYE | Class II | 2024-01-16 |
| K233512 | Rapid (6.0) | Ischemaview, Inc. | QIH | Class II | 2024-01-16 |
| K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2024-01-12 |
| DEN220040 | Fibresolve | Imvaria, Inc. | QWO | Class II | 2024-01-12 |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | LHN | Class II | 2024-01-12 |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | JAA | Class II | 2024-01-11 |
| K232285 | U-Lite PRO | Sonoscanner Sarl | IYN | Class II | 2024-01-11 |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS | Class II | 2024-01-09 |
| K231324 | DASI Dimensions (V1.0) | Dasi Simulations | QIH | Class II | 2024-01-08 |
| K232412 | LungQ v3.0.0 | Thirona BV | JAK | Class II | 2024-01-08 |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | MOS | Class II | 2024-01-08 |
| K231917 | VEA Align | Eos Imaging | QIH | Class II | 2024-01-05 |
| K231273 | ArcherQA (V1.0) | Wisdom Technologies., Inc. | IYE | Class II | 2024-01-05 |
| K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | IYN | Class II | 2024-01-04 |
| K232136 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2024-01-04 |
| K232589 | Horos MD | Icat Solutions, Ltd. | LLZ | Class II | 2024-01-03 |
| K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | IYO | Class II | 2023-12-29 |
| K230985 | Planmeca Viso | Planmeca Oy | OAS | Class II | 2023-12-28 |
| K230006 | Ankyras | Mentice Spain S.L. | PZO | Class II | 2023-12-28 |
| K231130 | TumorSight Viz | SimBioSys, Inc. | QIH | Class II | 2023-12-26 |
| K233109 | TP Pivot Pro Needle Guide | Civco Medical Solutions | ITX | Class II | 2023-12-22 |
| K231805 | qXR-LN | Qure.Ai Technologies | MYN | Class II | 2023-12-22 |
| DEN230020 | BioTraceIO Lite | Techsomed Medical Technologies , Ltd. | QZL | Class II | 2023-12-22 |
| K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-12-22 |
| K232293 | kallisio stentra oral stent | Kallisio, Inc. | IYE | Class II | 2023-12-22 |
| K233734 | Interson USB Ultrasound System | Interson Corporation | IYN | Class II | 2023-12-22 |
| K232479 | ART-Plan | Therapanacea | MUJ | Class II | 2023-12-22 |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | NFJ | Class II | 2023-12-21 |
| K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | IYO | Class II | 2023-12-21 |
| K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | LLZ | Class II | 2023-12-21 |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | Varian Medical Systems, Inc. | IYE | Class II | 2023-12-21 |
| K233465 | RadiForce MX317W | Eizo Corporation | PGY | Class II | 2023-12-21 |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2023-12-21 |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | IYO | Class II | 2023-12-21 |
| K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2023-12-20 |
| K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2023-12-20 |
| K231354 | Pocket Ultrasound System (C10) | Beijing Konted Medical Technology Co.,Ltd | IYN | Class II | 2023-12-20 |
| K231929 | iQ-solutions | Sydney Neuroimaging Analysis Centre Pty, Ltd. | QIH | Class II | 2023-12-18 |
| K231587 | MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2023-12-18 |
| K232957 | Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. | MUI | Class II | 2023-12-15 |
| K232384 | Videa Dental Assist | Videahealth, Inc. | MYN | Class II | 2023-12-15 |
| K231700 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | 2023-12-15 |
| K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2023-12-15 |
| K231825 | Panther TPS | Prowess, Inc. | MUJ | Class II | 2023-12-15 |
14,721 clearances in the Radiology panel. Data: openFDA.