Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 28
- Latest Decision
- 2025-07-11
Clearances · page 7 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2025-07-11 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | ITX | Class II | 2025-07-11 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | IYO | Class II | 2025-07-11 |
| K251169 | Vivid Pioneer | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-07-10 |
| K251830 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2025-07-10 |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2025-07-09 |
| K251766 | TumorSight Viz | SimBioSys, Inc. | QIH | Class II | 2025-07-08 |
| K243884 | TAVIPILOT | Caranx Medical | OWB | Class II | 2025-07-07 |
| K251863 | CustomSurg OrthoPlanner | Customsurg AG | LLZ | Class II | 2025-07-07 |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2025-07-03 |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2025-07-03 |
| K243679 | MammoScreen® (4) | Therapixel | QDQ | Class II | 2025-07-03 |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2025-07-03 |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | NQQ | Class II | 2025-07-02 |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | OXO | Class II | 2025-07-02 |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Elekta Solutions AB | IWB | Class II | 2025-07-02 |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | ITX | Class II | 2025-07-02 |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | QIH | Class II | 2025-07-01 |
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | POK | Class II | 2025-07-01 |
| K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | QIH | Class II | 2025-06-30 |
| K250670 | EchoConfidence (USA) | Mycardium AI Limited | QIH | Class II | 2025-06-30 |
| K250484 | PIUR tUS inside | Piur Imaging GmbH | QIH | Class II | 2025-06-30 |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | LHN | Class II | 2025-06-27 |
| K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | JAK | Class II | 2025-06-27 |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | IZI | Class II | 2025-06-27 |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | OAS | Class II | 2025-06-27 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | IYO | Class II | 2025-06-26 |
| K243142 | Cranial 4Pi Immobilization | Brainlab AG | IYE | Class II | 2025-06-23 |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | NQQ | Class II | 2025-06-23 |
| K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | JAK | Class II | 2025-06-20 |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote, S.p.A. | IYN | Class II | 2025-06-18 |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | IYN | Class II | 2025-06-18 |
| K243672 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | 2025-06-18 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | IYO | Class II | 2025-06-17 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | MUJ | Class II | 2025-06-17 |
| K250665 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2025-06-17 |
| K243666 | uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2025-06-17 |
| K250685 | Methinks NCCT Stroke | Methinks Software, S.L | QAS | Class II | 2025-06-16 |
| K244012 | Mosaic (V1.0.1) | Navier Medical | LLZ | Class II | 2025-06-16 |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | Class II | 2025-06-16 |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH | LNH | Class II | 2025-06-16 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | ITX | Class II | 2025-06-13 |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Brainlab AG | QIH | Class II | 2025-06-13 |
| K243234 | Second Opinion® CS | Pearl, Inc. | MYN | Class II | 2025-06-12 |
| K251153 | Aurora | Ge Medical Systems Israel | KPS | Class II | 2025-06-12 |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | OWB | Class II | 2025-06-10 |
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. | QIH | Class II | 2025-06-10 |
| K251009 | Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. | QIH | Class II | 2025-06-06 |
| K243667 | Sonic DL | Ge Medical Systems, LLC | LNH | Class II | 2025-06-05 |
| K250800 | UroNav 4 | Philips DS North America, LLC | LLZ | Class II | 2025-06-05 |
| K243703 | TechLive | DeepHealth, Inc. | LLZ | Class II | 2025-06-05 |
| K251456 | BrightHeart View Classifier | Brightheart | QIH | Class II | 2025-06-05 |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. | LNH | Class II | 2025-06-04 |
| K243810 | TraumaCad Neo (1.1) | Brainlab , Ltd. | QIH | Class II | 2025-06-04 |
| K243005 | AudaxCeph Cephalogram Analysis Software | Audax D.O.O. | QIH | Class II | 2025-05-30 |
| DEN240047 | Allix5 | Clairity, Inc. | SEZ | Class II | 2025-05-30 |
| K243863 | Opulus Lymphoma Precision | Roche Molecular Systems, Inc. | QIH | Class II | 2025-05-30 |
| K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | LNH | Class II | 2025-05-30 |
| K250024 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-05-30 |
| K251406 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2025-05-30 |
| K250543 | Voluson Performance 16; Voluson Performance 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-05-29 |
| K243378 | Rapid MLS | Ischemaview, Inc. | QIH | Class II | 2025-05-28 |
| K250367 | CoLumboX | Smart Soft Healthcare AD | QIH | Class II | 2025-05-28 |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | QKB | Class II | 2025-05-28 |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | IZL | Class II | 2025-05-28 |
| K242594 | DEEPECHO | Deepecho | IYN | Class II | 2025-05-23 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | IYO | Class II | 2025-05-23 |
| K250005 | Clever One | Ewoosoft Co., Ltd. | QIH | Class II | 2025-05-23 |
| K243989 | Second Opinion® 3D | Pearl, Inc. | QIH | Class II | 2025-05-23 |
| K243762 | Synapse 3D Base Tools (V7.0) | Fujifilm Corporation | QIH | Class II | 2025-05-21 |
| K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2025-05-21 |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2025-05-21 |
| K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | LNH | Class II | 2025-05-21 |
| K251109 | SMARTDent | Ray Co., Ltd. | LLZ | Class II | 2025-05-21 |
| K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | JAK | Class II | 2025-05-20 |
| K243301 | MapRT | Vision Rt, Ltd. | IYE | Class II | 2025-05-19 |
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-05-19 |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | OWB | Class II | 2025-05-19 |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. | OWB | Class II | 2025-05-16 |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | IYE | Class II | 2025-05-16 |
| K244008 | Spectral CT | Philips Medical Systems Technologies , Ltd. | JAK | Class II | 2025-05-16 |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | OEB | Class II | 2025-05-16 |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2025-05-16 |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | IYN | Class II | 2025-05-16 |
| K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-05-16 |
| K242519 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | IYN | Class II | 2025-05-15 |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | 2025-05-14 |
| K242437 | Smile Dx® | Cube Click, Inc. | MYN | Class II | 2025-05-14 |
| K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | Canon Medical Systems Corporation | IYN | Class II | 2025-05-13 |
| K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2025-05-12 |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | LHN | Class II | 2025-05-12 |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | JAQ | Class II | 2025-05-09 |
| K243230 | Second Opinion® BLE | Pearl, Inc. | QIH | Class II | 2025-05-09 |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | IYN | Class II | 2025-05-09 |
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | Leltek, Inc. | IYN | Class II | 2025-05-08 |
| K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp. | QIH | Class II | 2025-05-08 |
| K242670 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | IYN | Class II | 2025-05-08 |
| K243684 | BrightHeart View Classifier | Brightheart | QIH | Class II | 2025-05-07 |
| K241980 | !M1 | Solutions For Tomorrow AB | IZL | Class II | 2025-05-06 |
| K250160 | ANKYRAS | Mentice Spain S.L. | PZO | Class II | 2025-05-06 |
14,721 clearances in the Radiology panel. Data: openFDA.