Radiology
14,649 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| EzDent-i / E2 / Prora View/ Smart M Viewer (K222145) | Ewoosoft Co., Ltd. | 2022-08-12 |
| TeraRecon Neuro (K220349) | Terarecon,Inc. | 2022-08-12 |
| AI-Rad Companion (Pulmonary) (K213713) | Siemens Healthcare GmbH | 2022-08-11 |
| Medical image processing software (K220910) | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | 2022-08-11 |
| dS Sentinelle Breast 16ch 3.0T Coil (K213727) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 |
| dS Sentinelle Breast 16ch 1.5T Coil (K213735) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 |
| ClearPoint Maestro Brain Model (K213645) | ClearPoint Neuro, Inc. | 2022-08-08 |
| Dolphin Imaging 12.0 (K222072) | Patterson Dental Supply, Inc. | 2022-08-08 |
| Neurophet SCALE PET (K221405) | Neurophet., Inc. | 2022-08-05 |
| Customize (K221432) | 3D-Side S.A. | 2022-08-03 |
| Transpara 1.7.2 (K221347) | Screenpoint Medical B.V. | 2022-08-03 |
| X-ray Flat Panel Detectors (CareView 1800 RF) (K221549) | Careray Digital Medical Technology Co., Ltd. | 2022-08-01 |
| Deep Learning Image Reconstruction (K220961) | Ge Healthcare Japan Corporation | 2022-07-29 |
| ABMD Software (K213760) | HeartLung Corporation | 2022-07-29 |
| TRON (K221230) | Xoran Technologies, LLC | 2022-07-28 |
| Trinias (K221922) | Shimadzu Corporation Medical Systems Division | 2022-07-28 |
| Swoop Portable MR Imaging System (K221923) | Hyperfine, Inc. | 2022-07-28 |
| cvi42 Auto Imaging Software Application (K213998) | Circle Cardiovascular Imaging, Inc. | 2022-07-28 |
| OTC DDR (K221853) | Konica Minolta Healthcare Americas, Inc. | 2022-07-27 |
| LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (K221567) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-07-26 |
| Viz SDH (K220439) | Viz. Ai, Inc. | 2022-07-25 |
| EchoPAC Software Only, EchoPAC Plug-in (K220940) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-22 |
| 10HQ701G-B (K221461) | Lg Electronics.Inc | 2022-07-22 |
| AI4CMR v1.0 (K220624) | Ai4medimaging Medical Solutions S.A. | 2022-07-22 |
| Vivid E80, Vivid E90, Vivid E95 (K220882) | Ge Medical Systems Ultrasound And | 2022-07-22 |
| PreXion3D Explorer PRO (K221525) | Prexion Corporation | 2022-07-22 |
| FX SPS (K213922) | Pixee Medical | 2022-07-22 |
| 14HQ701G-B (K221394) | Lg Electronics.Inc | 2022-07-22 |
| AutoSeg (K220039) | Ai Medic, Inc. | 2022-07-20 |
| Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) (K221512) | Vieworks Co., Ltd. | 2022-07-20 |
| Libby Echo:Prio (K220956) | Dyad Medical, Inc. | 2022-07-20 |
| BrainInsight (K220815) | Hyperfine, Inc. | 2022-07-19 |
| ARTIS icono (Ceiling Configuration) (K221516) | Siemens Medical Solutions USA, Inc. | 2022-07-19 |
| Planmed Clarity 2D, Planmed Clarify S (K211720) | Planmed OY | 2022-07-18 |
| Vivid T8, Vivid T9 (K221147) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-18 |
| Vivid iq (K221148) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2022-07-18 |
| PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (K221803) | Sedecal., Sa. | 2022-07-18 |
| Vivid S60N, Vivid S70N (K220619) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-15 |
| Digital Radiography CXDI-Pro, Digital Radiography D1 (K221876) | Canon, Inc. | 2022-07-15 |
| 17HQ701G-B (K221434) | Lg Electronics.Inc | 2022-07-13 |
| syngo.CT Extended Functionality (K221727) | Siemens Medical Solutions USA, Inc. | 2022-07-13 |
| NAEOTOM Alpha, Scan&GO Software (K220814) | Siemens Medical Solutions USA, Inc. | 2022-07-12 |
| Veuron-Brain-mN1 (K203279) | Heuron Co., Ltd. | 2022-07-12 |
| MINE ALNU (Model: Mine 2.1) (K213405) | Hdt Co., Ltd. | 2022-07-10 |
| Transcranial Doppler Ultrasound System (K213009) | Shenzhen Delica Medical Equipment Co., Ltd. | 2022-07-08 |
| ProstatID (K212783) | Scanmed, LLC | 2022-07-08 |
| Functional MR V1.0 (K221426) | Olea Medical S.A.S. | 2022-07-06 |
| i_ Field 1.5T Superconducting Magnetic Resonance Imaging System (K221025) | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2022-07-01 |
| Bladder Scanner, Model Name:M5 (K213488) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2022-07-01 |
| V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K220975) | Samsung Medison Co., Ltd. | 2022-06-29 |
| Flat Panel Detector (K221714) | Iray Technology Taicang , Ltd. | 2022-06-29 |
| ARTIS pheno (VE21) System (K220409) | Siemens Medical Solutions USA, Inc. | 2022-06-29 |
| ARTIS icono (VE21) System (K220432) | Siemens Medical Solutions USA, Inc. | 2022-06-29 |
| Venue (K220851) | GE Medical Systems | 2022-06-27 |
| Venue Fit (K220848) | GE Medical Systems | 2022-06-27 |
| OTOPLAN (K220300) | Cascination AG | 2022-06-24 |
| MAGNETOM Free.Max, MAGNETOM Free.Star (K220575) | Siemens Medical Solutions USA, Inc. | 2022-06-24 |
| FlexBoardTM, EagleBoardTM, BreastBoard SXTM (K213439) | Macromedics BV | 2022-06-24 |
| Axial3D Cloud Segmentation Service (K221511) | Axial Medical Printing Limited | 2022-06-23 |
| CoLumbo (K220497) | Smart Soft Healthcare AD | 2022-06-23 |
| Ultrasound System SONIMAGE MX1 (K220993) | Konica Minolta, Inc. | 2022-06-23 |
| Venue Go (K220800) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-21 |
| Syngo Carbon Space VA20A (K213665) | Siemens Healthcare GmbH | 2022-06-21 |
| ElucidVivo A.3 (K221463) | Elucid Bioimaging, Inc. | 2022-06-17 |
| ARIA Radiation Therapy Management (v16.1 MR3) (K221408) | Varian Medical Systems, Inc. | 2022-06-17 |
| ART-PLAN (K220813) | Therapanacea | 2022-06-17 |
| RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System (K221117) | Samsung Medison Co., Ltd. | 2022-06-17 |
| Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (K213504) | Canon Medical Systems Corporation | 2022-06-16 |
| Wireless Digital Flat Panel Detector (K221345) | Iray Technology Taicang , Ltd. | 2022-06-16 |
| ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) (K221448) | Varian Medical Systems, Inc. | 2022-06-15 |
| SurgiCase Viewer (K213684) | Materialise NV | 2022-06-15 |
| ACUSON Sequoia Diagnostic Ultrasound System (K221500) | Siemens Medical Solutions USA, Inc. | 2022-06-14 |
| Digital Radiography CXDI-Elite, Digital Radiography E1 (K221620) | Canon, Inc. | 2022-06-14 |
| iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System (K221081) | First Source, Inc. | 2022-06-13 |
| Swoop Portable MR Imaging System (K221393) | Hyperfine, Inc. | 2022-06-10 |
| MediLab (K221065) | Sigma Scientific Services, LLC | 2022-06-10 |
| HD60 Series Ultrasound Diagnostic System (K213862) | Qingdao Hisense Medical Equipment Co., Ltd. | 2022-06-08 |
| AIR Recon DL (K213717) | Ge Medical Systems,Llc (Ge Healthcare) | 2022-06-08 |
| D²RS and D²RS 9090 (K221335) | Stephanix | 2022-06-07 |
| Natural Rubber Latex Ultrasound Transducer Probe Covers (K213087) | Global Protection Corp. | 2022-06-07 |
| Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (K220358) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-06 |
| BriefCase (K221314) | Aidoc Medical , Ltd. | 2022-06-03 |
| 3D Anatomic Models (K220205) | Ricoh USA, Inc. | 2022-06-03 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K213977) | Varian Medical Systems, Inc. | 2022-06-03 |
| 21HQ613D (K221061) | Lg Electronics.Inc | 2022-06-03 |
| Rayvolve (K220164) | Azmed Sas | 2022-06-02 |
| AneuGuide (K213838) | ArteryFlow Technology Co., Ltd. | 2022-06-01 |
| Rapid LVO (K221248) | Ischemaview, Inc. | 2022-05-31 |
| EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows (K213731) | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 |
| EchoNavigator R4.0 (K221270) | Philips Medical Systems Nederland B.V. | 2022-05-31 |
| Aspire Cristalle (K212873) | Fujifilm Corporation | 2022-05-27 |
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |
| SwiftMR (K220416) | Airs Medical, Inc. | 2022-05-25 |
| ON3D (K221000) | 3D Ons, Inc. | 2022-05-23 |
| SCENARIA View (K213829) | Fujifilm Healthcare Corporation | 2022-05-23 |
| syngo Dynamics (Version VA40E) (K220832) | Siemens Medical Solutions USA, Inc. | 2022-05-20 |
| PAPAYA 3D & PAPAYA 3D Plus (K220392) | Genoray Co., Ltd. | 2022-05-19 |
| CoverScan v1 (K212565) | Perspectum, Ltd. | 2022-05-19 |
| BriefCase (K221240) | Aidoc Medical , Ltd. | 2022-05-17 |
| MULTIX Impact E (K220919) | Siemens Medical Solutions USA, Inc. | 2022-05-17 |
Track Radiology automatically
Every clearance here is in the API, with alerts when new ones post.