Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2025-09-23
Clearances · page 6 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251987 | Rapid Aortic Measurements | Ischemaview, Inc. | QIH | Class II | 2025-09-23 |
| K243645 | IC-Flow Imaging System 2.0 | Diagnostic Green GmbH | IZI | Class II | 2025-09-22 |
| K251002 | Videa Dental AI | Videahealth, Inc. | MYN | Class II | 2025-09-19 |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | 2025-09-19 |
| K250369 | Axial3D Insight | Axial Medical Printing Limited | QIH | Class II | 2025-09-18 |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | ITX | Class II | 2025-09-18 |
| K251386 | ECHELON Synergy | Fujifilm Corporation | LNH | Class II | 2025-09-17 |
| K251650 | Insight Enhanced DRF (EN-1002-01) | Imaging Engineering, LLC | JAA | Class II | 2025-09-16 |
| K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | Class II | 2025-09-15 |
| K251820 | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-09-12 |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2025-09-12 |
| K243864 | BONX805 | Bontech Co., Ltd. | IZL | Class II | 2025-09-12 |
| K251368 | FETOLY | Diagnoly | IYN | Class II | 2025-09-12 |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | LHN | Class II | 2025-09-12 |
| K251399 | SIGNA Sprint | Ge Medical Systems, LLC | LNH | Class II | 2025-09-11 |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | LLZ | Class II | 2025-09-11 |
| K244002 | AngioWaveNet | Angiowave Imaging, Inc. | QIH | Class II | 2025-09-10 |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | LLZ | Class II | 2025-09-09 |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | KPS | Class II | 2025-09-09 |
| K251682 | MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) | LNH | Class II | 2025-09-09 |
| K251072 | Segmentron Viewer | DGNCT, LLC | QIH | Class II | 2025-09-09 |
| K250928 | OmniTom Elite with PCD | Neurologica Corporation | JAK | Class II | 2025-09-08 |
| K251610 | qER-CTA (v1.0) | Qure.Ai Technologies | QAS | Class II | 2025-09-08 |
| K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | QTZ | Class II | 2025-09-08 |
| K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-09-05 |
| K251022 | 3D-SHAPER | 3D-Shaper Medical S.L | KGI | Class II | 2025-09-05 |
| K250064 | Dose+ (1.0) | Mvision AI OY | MUJ | Class II | 2025-09-04 |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | QAS | Class II | 2025-09-04 |
| K251168 | Image Suite | Carestream Health, Inc. | LLZ | Class II | 2025-09-04 |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte. , Ltd. | QIH | Class II | 2025-09-04 |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | IYE | Class II | 2025-09-03 |
| K252539 | Tempus Pixel | Arterys, Inc. | QIH | Class II | 2025-09-03 |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | MYN | Class II | 2025-09-02 |
| K251408 | OsteoSight Hip (v1) | Naitive Technologies, Ltd. | SAO | Class II | 2025-09-02 |
| K250290 | SurgiTwin | Twinsight | LLZ | Class II | 2025-08-29 |
| K243859 | PRAEVAorta®2 | Nurea | QIH | Class II | 2025-08-29 |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM Sonosite, Inc. | IYN | Class II | 2025-08-29 |
| K251484 | CT:VQ | 4Dmedical Limited | JAK | Class II | 2025-08-28 |
| K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | PGY | Class II | 2025-08-28 |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | KPR | Class II | 2025-08-28 |
| K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | QIH | Class II | 2025-08-27 |
| K252526 | Rapid DeltaFuse | Ischemaview, Inc. | LLZ | Class II | 2025-08-26 |
| K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | QAS | Class II | 2025-08-26 |
| K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | LLZ | Class II | 2025-08-25 |
| K251443 | PROMO | DRGEM Corporation | IZL | Class II | 2025-08-22 |
| K252362 | GBrain MRI | Galileo Cds, Inc. | QIH | Class II | 2025-08-22 |
| K243685 | MammoScreen BD | Therapixel | QIH | Class II | 2025-08-22 |
| K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-08-22 |
| K251029 | Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. | LNH | Class II | 2025-08-21 |
| K251837 | Salix Coronary Plaque (V1.0.0) | Artrya Limited | QIH | Class II | 2025-08-20 |
| K251481 | 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 | 2025-08-20 |
| K251590 | Methinks CTA Stroke | Methinks Software, S.L | QAS | Class II | 2025-08-20 |
| K251747 | VEA Align; spineEOS | Eos Imaging | QIH | Class II | 2025-08-15 |
| K250170 | PHAROS | Brightonix Imaging | KPS | Class II | 2025-08-15 |
| K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | QIH | Class II | 2025-08-12 |
| K232456 | RW-1 | Mediott, Inc. | LLZ | Class II | 2025-08-11 |
| K251873 | Saige-Dx | DeepHealth, Inc. | QDQ | Class II | 2025-08-11 |
| K251629 | UNiD Spine Analyzer | Medicrea International S.A.S. (Medtronic) | QIH | Class II | 2025-08-07 |
| K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-CARE , Ltd. | LLZ | Class II | 2025-08-07 |
| K252239 | InVision 3T Recharge Operating Suite | Imris Imaging, Inc. | LNH | Class II | 2025-08-06 |
| K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. | LLZ | Class II | 2025-08-06 |
| K244016 | iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. | LLZ | Class II | 2025-08-05 |
| K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2025-08-05 |
| K250434 | trophon2 | Nanosonics | OUJ | Class II | 2025-08-05 |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | IZL | Class II | 2025-08-04 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | IYO | Class II | 2025-08-01 |
| K250941 | Revolution Vibe | Ge Medical Systems, LLC | JAK | Class II | 2025-08-01 |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | KPR | Class II | 2025-08-01 |
| K250597 | REMEX Xcam6 | Remedi, Inc. | IZL | Class II | 2025-07-31 |
| K243341 | Genius AI Detection 2.0 | Hologic, Inc. | QDQ | Class II | 2025-07-31 |
| K250738 | YSIO X.pree | Siemens Medical Solutions | KPR | Class II | 2025-07-31 |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2025-07-31 |
| K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | QIH | Class II | 2025-07-30 |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | IZL | Class II | 2025-07-29 |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2025-07-29 |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2025-07-28 |
| K250970 | Marie | Leo Cancer Care | JAK | Class II | 2025-07-25 |
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-07-25 |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2025-07-24 |
| K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | LLZ | Class II | 2025-07-23 |
| K250716 | IMAGE ONE | Infomed Software, S.L. | LLZ | Class II | 2025-07-23 |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | MQB | Class II | 2025-07-22 |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2025-07-22 |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG | OWB | Class II | 2025-07-22 |
| K250686 | GyriCalc (Version 1.0.0) | Neurospectrum Insights Corp. | LLZ | Class II | 2025-07-22 |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2025-07-18 |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | IZL | Class II | 2025-07-18 |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2025-07-17 |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | MOS | Class II | 2025-07-17 |
| K243420 | HESTIA | Genoray Co., Ltd. | MUE | Class II | 2025-07-17 |
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2025-07-17 |
| K251198 | HyperVue Software | Spectrawave, Inc. | NQQ | Class II | 2025-07-16 |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH | Class II | 2025-07-16 |
| K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2025-07-16 |
| K251151 | Rapid CTA 360 | Ischemaview | QAS | Class II | 2025-07-16 |
| K242818 | IsoSphere | Isoaid, LLC | KXK | Class II | 2025-07-15 |
| K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2025-07-15 |
| K250120 | GECHO | Narnar, LLC | LLZ | Class II | 2025-07-14 |
| K251096 | PeekMed web | Peek Health, S.A. | QIH | Class II | 2025-07-14 |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | OWB | Class II | 2025-07-14 |
14,721 clearances in the Radiology panel. Data: openFDA.