Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2026-05-15
Clearances · page 3 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K261273 | Neurophet AQUA | Neurophet., Inc. | QIH | Class II | 2026-05-15 |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | QIH | Class II | 2026-05-15 |
| K261289 | UNiD Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | QIH | Class II | 2026-05-15 |
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd | IYN | Class II | 2026-05-15 |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | Sonoscape Medical Corp. | IYN | Class II | 2026-05-15 |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | QIH | Class II | 2026-05-15 |
| K253078 | ART.1-US | Seetreat Pty, Ltd. | MUJ | Class II | 2026-05-14 |
| K261317 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2026-05-14 |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | IYN | Class II | 2026-05-14 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | LLZ | Class II | 2026-05-14 |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | IZL | Class II | 2026-05-14 |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | IZI | Class II | 2026-05-13 |
| K260032 | Morph | BeauBrain Healthcare, Inc. | QIH | Class II | 2026-05-13 |
| K260378 | Rayvolve | AZmed | QBS | Class II | 2026-05-12 |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | MYN | Class II | 2026-05-11 |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2026-05-11 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | LLZ | Class II | 2026-05-08 |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | IYE | Class II | 2026-05-08 |
| K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | IYN | Class II | 2026-05-05 |
| K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-05-05 |
| K260716 | Neowise | Cefla S.C. | LLZ | Class II | 2026-05-04 |
| K252954 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | QFM | Class II | 2026-05-04 |
| K252503 | Intelligent NR | Canon, Inc. | OWB | Class II | 2026-04-30 |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | QIH | Class II | 2026-04-30 |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2026-04-29 |
| K260589 | ES-Series | E-Scopics | IYN | Class II | 2026-04-29 |
| K253682 | DeepHealth ProstateAI | Quantib B.V. | QDQ | Class II | 2026-04-29 |
| K252337 | EdgeFlow Gel Pad | Edgecare, Inc. | MUI | Class II | 2026-04-24 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2026-04-24 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | LLZ | Class II | 2026-04-24 |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL | NQQ | Class II | 2026-04-24 |
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | MOS | Class II | 2026-04-23 |
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | QDQ | Class II | 2026-04-23 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | LLZ | Class II | 2026-04-23 |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | LHN | Class II | 2026-04-23 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2026-04-23 |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | QIH | Class II | 2026-04-23 |
| K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | 2026-04-22 |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | 2026-04-22 |
| K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI | Class II | 2026-04-20 |
| K252332 | Folliscan | Mim Fertility | QIH | Class II | 2026-04-20 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | IYO | Class II | 2026-04-17 |
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | IYE | Class II | 2026-04-15 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | QIH | Class II | 2026-04-14 |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2026-04-14 |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | QIH | Class II | 2026-04-10 |
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | KPR | Class II | 2026-04-10 |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | QIH | Class II | 2026-04-10 |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | QKB | Class II | 2026-04-10 |
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | QKB | Class II | 2026-04-10 |
| K252708 | Relu Cloud | Relu BV | QIH | Class II | 2026-04-10 |
| K260462 | RCT800 | Ray Co., Ltd. | OAS | Class II | 2026-04-09 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | IYO | Class II | 2026-04-09 |
| K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | IXI | Class II | 2026-04-06 |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | IYN | Class II | 2026-04-06 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | LNH | Class II | 2026-04-06 |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2026-04-03 |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | IYE | Class II | 2026-04-03 |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | OWB | Class II | 2026-04-02 |
| K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | IYN | Class II | 2026-04-02 |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2026-04-01 |
| K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | QIH | Class II | 2026-04-01 |
| K253582 | Medical Imaging Calibration Feature (MICF) | Apple, Inc. | SHN | Class I | 2026-04-01 |
| K253029 | RW-1 | Mediott, Inc. | LLZ | Class II | 2026-03-31 |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | OAS | Class II | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | LLZ | Class II | 2026-03-30 |
| K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | QIH | Class II | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | LLZ | Class II | 2026-03-27 |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-03-27 |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | POK | Class II | 2026-03-27 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | JAK | Class II | 2026-03-27 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | LNH | Class II | 2026-03-27 |
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | IYN | Class II | 2026-03-27 |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2026-03-27 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2026-03-27 |
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | QKB | Class II | 2026-03-27 |
| K253775 | SwiftMR | Airs Medical, Inc. | QIH | Class II | 2026-03-26 |
| K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | QDQ | Class II | 2026-03-26 |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | LHN | Class II | 2026-03-25 |
| K252421 | JLK-NCCT | JLK, Inc. | QAS | Class II | 2026-03-24 |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | MUE | Class II | 2026-03-24 |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-03-24 |
| K252099 | Trinias | Shimadzu Corporation | OWB | Class II | 2026-03-24 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | JAK | Class II | 2026-03-23 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2026-03-23 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | LNH | Class II | 2026-03-20 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2026-03-20 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | JAK | Class II | 2026-03-20 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | 2026-03-20 |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | QKB | Class II | 2026-03-19 |
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | IYE | Class II | 2026-03-18 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | MUJ | Class II | 2026-03-18 |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | QIH | Class II | 2026-03-17 |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | QIH | Class II | 2026-03-16 |
| K252433 | Sonio Detect (v3) | Sonio | IYN | Class II | 2026-03-16 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | LNH | Class II | 2026-03-13 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | JAK | Class II | 2026-03-13 |
| K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | Class II | 2026-03-13 |
| K260479 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | LLZ | Class II | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | LLZ | Class II | 2026-03-13 |
14,721 clearances in the Radiology panel. Data: openFDA.