Radiology
14,649 FDA 510(k) clearances · Medical specialty
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Bladder Scanner (K230986) | Avantsonic Technology Co., Ltd. | 2023-12-29 |
| Ankyras (K230006) | Mentice Spain S.L. | 2023-12-28 |
| Planmeca Viso (K230985) | Planmeca Oy | 2023-12-28 |
| TumorSight Viz (K231130) | SimBioSys, Inc. | 2023-12-26 |
| Interson USB Ultrasound System (K233734) | Interson Corporation | 2023-12-22 |
| TP Pivot Pro™ Needle Guide (K233109) | Civco Medical Solutions | 2023-12-22 |
| ART-Plan (K232479) | Therapanacea | 2023-12-22 |
| MAGNETOM Sola; MAGNETOM Altea (K232535) | Siemens Medical Solutions USA, Inc. | 2023-12-22 |
| BioTraceIO Lite (DEN230020) | Techsomed Medical Technologies , Ltd. | 2023-12-22 |
| qXR-LN (K231805) | Qure.Ai Technologies | 2023-12-22 |
| kallisio stentra™ oral stent (K232293) | Kallisio, Inc. | 2023-12-22 |
| RadiForce MX317W (K233465) | Eizo Corporation | 2023-12-21 |
| syngo Virtual Cockpit (VB10A) (K232744) | Siemens Healthcare GmbH | 2023-12-21 |
| Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) (K231889) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 |
| CALLISTO eye (K232944) | Carl Zeiss Meditec, AG | 2023-12-21 |
| TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) (K232870) | Varian Medical Systems, Inc. | 2023-12-21 |
| HM70 EVO Diagnostic Ultrasound System (K233112) | Samsung Medison Co., Ltd. | 2023-12-21 |
| iSR`obot Mona Lisa 2.0 (K232320) | Biobot Surgical Pte., Ltd. | 2023-12-21 |
| uOmnispace.MI (K233176) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-12-20 |
| syngo Application Software (K230955) | Siemens Medical Solutions USA, Inc. | 2023-12-20 |
| Pocket Ultrasound System (C10) (K231354) | Beijing Konted Medical Technology Co.,Ltd | 2023-12-20 |
| iQ-solutions (K231929) | Sydney Neuroimaging Analysis Centre Pty, Ltd. | 2023-12-18 |
| MAGNETOM Cima.X (K231587) | Siemens Medical Solutions USA, Inc. | 2023-12-18 |
| Sterile and Non-Sterile Ultrasound Gels (K232957) | Jianerkang Medical Co., Ltd. | 2023-12-15 |
| Videa Dental Assist (K232384) | Videahealth, Inc. | 2023-12-15 |
| ARTIS pheno (VE30A) (K230949) | Siemens Medical Solutions USA, Inc. | 2023-12-15 |
| Panther TPS (K231825) | Prowess, Inc. | 2023-12-15 |
| Ziehm Vision FD (K231700) | Ziehm Imaging GmbH | 2023-12-15 |
| ARTIS icono (VE30A) (K230950) | Siemens Medical Solutions USA, Inc. | 2023-12-14 |
| StrokeViewer Perfusion (K231570) | Nico-Lab B.V. | 2023-12-14 |
| bright CT (K231181) | Dentium Co., Ltd (Ict Branch) | 2023-12-14 |
| Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (K231666) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 |
| QP-Brain® (K232231) | Quibim S.L. | 2023-12-13 |
| fMRI Hardware System (K232680) | Nordicneurolab AS | 2023-12-13 |
| TeleScan (K233634) | Bb Imaging | 2023-12-12 |
| Ziehm Solo FD (K231669) | Ziehm Imaging GmbH | 2023-12-12 |
| 24HR513C (K232985) | Lg Electronics.Inc | 2023-12-11 |
| Transpara Density 1.0.0 (K232096) | Screenpoint Medical B.V. | 2023-12-11 |
| Nio Color 8MP (MDNC-8132) (K233693) | Barco N.V. | 2023-12-11 |
| DTX Studio Clinic (4.0) (K231898) | Nobel Biocare AB | 2023-12-08 |
| Bonelogic (K223757) | Disior, Ltd. | 2023-12-08 |
| LOGIQ Totus (K232381) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-12-07 |
| Myocardial Strain Software Application (K232661) | Circle Cardiovascular Imaging | 2023-12-07 |
| SOMATOM Pro.Pulse (K232206) | Siemens Medical Solutions USA, Inc. | 2023-12-06 |
| Aquilion Serve SP (TSX-307B/1) V1.3 (K233334) | Canon Medical Systems Corporation | 2023-12-06 |
| Sonosite LX Ultrasound System (K233597) | FUJIFILM Sonosite, Inc. | 2023-12-06 |
| Ceevra Reveal 3+ (K233568) | Ceevra, Inc. | 2023-12-05 |
| Adravision Perio (K232440) | Adra Corporation | 2023-12-05 |
| Syngo Carbon Clinicals (K232856) | Siemens Healthcare GmbH | 2023-12-01 |
| syngo.CT Dual Energy (K232155) | Siemens Medical Solutions USA, Inc. | 2023-11-30 |
| EPIQ Series Diagnostic Ultrasound System (K233545) | Philips Ultrasound, LLC | 2023-11-30 |
| 6440 MyLabX90 (K230179) | Esaote, S.p.A. | 2023-11-29 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis (K231482) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-11-29 |
| MULTIX Impact E (K233532) | Siemens Medical Solutions | 2023-11-29 |
| BriefCase-Quantification (K231631) | Aidoc Medical , Ltd. | 2023-11-28 |
| syngo.via MI Workflows; Scenium; syngo MBF (K232000) | Siemens Medical Solutions USA, Inc. | 2023-11-28 |
| Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System (K232988) | Canon Medical Systems Corporation | 2023-11-21 |
| TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (K233049) | Cs Medical, LLC | 2023-11-21 |
| Brainomix 360 Triage Stroke (K232496) | Brainomix Limited | 2023-11-21 |
| TraumaCad Neo (K231498) | Brainlab , Ltd. | 2023-11-20 |
| Ziehm Vision RFD (K231692) | Ziehm Imaging GmbH | 2023-11-20 |
| ARIETTA x10 (K231941) | FUJIFILM Healthcare Americas Corporation | 2023-11-20 |
| Harmony (K232555) | Topcon Healthcare Solutions | 2023-11-20 |
| AI Platform (AIP001) (K232501) | Exo, Inc. | 2023-11-17 |
| CT Lung Ventilation Analysis Software (CT:V) (K232392) | 4Dmedical Limited | 2023-11-16 |
| EXPD 4343D; EXPD 3643D (K232753) | DRTECH Corporation | 2023-11-16 |
| XPLUS 35 Series (XPLUS 35, XPLUS 35FD) (K233200) | GEMSS HEALTHCARE CO., LTD. | 2023-11-16 |
| Axial3D Insight (K232841) | Axial Medical Printing Limited | 2023-11-15 |
| BinkieRT (K231852) | Papricalab | 2023-11-15 |
| VitroPRO (K231783) | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| MAGNETOM Avanto fit; MAGNETOM Skyra fit (K232494) | Siemens Medical Solutions USA, Inc. | 2023-11-14 |
| BrainSpec Core™ Software (K230856) | Brainspec, Inc. | 2023-11-14 |
| BriefCase-Quantification (K232083) | Aidoc Medical , Ltd. | 2023-11-13 |
| Clarius Bladder AI (K232257) | Clarius Mobile Health Corp. | 2023-11-13 |
| MAGNETOM Free.Max; MAGNETOM Free.Star (K231617) | Siemens Medical Solutions USA, Inc. | 2023-11-09 |
| BraveCX (K223754) | Bering, Ltd. | 2023-11-09 |
| BriefCase-Quantification (K230534) | Aidoc Medical , Ltd. | 2023-11-08 |
| Contour ProtégéAI (K231765) | Mim Software, Inc. | 2023-11-08 |
| LOGIQ E10s, LOGIQ Fortis (K231989) | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023-11-07 |
| LOGIQ E10 (K231966) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-11-07 |
| Lunit INSIGHT DBT (K231470) | Lunit, Inc. | 2023-11-06 |
| aprevo® Digital Segmentation (K231955) | Carlsmed, Inc. | 2023-11-03 |
| Halcyon, Ethos Radiotherapy System (K232113) | Varian Medical Systems, Inc. | 2023-11-03 |
| LOGIQ e (K232186) | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023-11-03 |
| XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 (K230800) | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 |
| BriefCase-Triage (K232751) | Aidoc Medical , Ltd. | 2023-10-30 |
| Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (K231965) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023-10-30 |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System (K232145) | Siemens Medical Solutions USA, Inc. | 2023-10-30 |
| PodSKAN HF Diagnostic X-ray System (K231761) | Skanray Technologies Limited | 2023-10-27 |
| SwiftMR (K230854) | Airs Medical, Inc. | 2023-10-27 |
| MeVis Liver Suite (K232045) | MeVis Medical Solutions AG | 2023-10-27 |
| Digital Expert Access with Remote Scanning (K232346) | GE Healthcare | 2023-10-27 |
| TE Air Diagnostic Ultrasound System (K231685) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-10-26 |
| Lumify Diagnostic Ultrasound System (K232500) | Philips Ultrasound | 2023-10-26 |
| K3900 Ultrasound Imaging System (K230511) | Maui Imaging | 2023-10-25 |
| AcuityUDR (K231995) | Radmedix, LLC | 2023-10-25 |
| Rapid SDH (K232436) | Ischemaview, Inc. | 2023-10-25 |
| spineEOS (K232086) | Eos Imaging | 2023-10-24 |
| 16 Breast Coil (K233348) | Philips Medical System Nederlands B.V. | 2023-10-24 |
| Aco Apache Ultrasound System (K231509) | Aco Healthcare Co., Ltd. | 2023-10-24 |
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Every clearance here is in the API, with alerts when new ones post.