Radiology
14,649 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| AVIEW (K200714) | Coreline Soft Co., Ltd. | 2020-08-26 |
| FIRMM (K201141) | Nous Imaging, Inc. | 2020-08-26 |
| BriefCase (K201020) | Aidoc Medical , Ltd. | 2020-08-26 |
| EzDent-i/ E2/ Prora View/ Smart M Viewer (K202116) | Ewoosoft Co., Ltd. | 2020-08-21 |
| DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System (K201693) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-08-21 |
| CUBEScan BioCon-1100 (K201995) | Mcube Technology Co., Ltd. | 2020-08-19 |
| Cranial 4Pi Immobilization (K202050) | Brainlab AG | 2020-08-19 |
| Universal Cylinder Applicator Family (K193240) | Varian Medical Systems, Inc. | 2020-08-17 |
| 3D Auto LAA (K201352) | Philips Health Care | 2020-08-17 |
| TOMTEC-ARENA (K201632) | Tomtec Imaging Systems GmbH | 2020-08-14 |
| The AIO Solution 3.0 (K202068) | Orfit Industries NV | 2020-08-14 |
| Syngo.via RT Image Suite (K201444) | Siemens Medical Solutions USA, Inc. | 2020-08-13 |
| Braid (K200822) | Braid.Health | 2020-08-13 |
| Limbus Contour (K201232) | Limbus Ai, Inc. | 2020-08-13 |
| ImagenSPECT 3.0 (K201933) | Cardiovascular Imaging Technologies | 2020-08-11 |
| Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K201722) | Hyperfine Research, Inc. | 2020-08-11 |
| Accipiolx (K201310) | Maxq AL , Ltd. | 2020-08-07 |
| X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) (K201932) | Careray Digital Medical System Co., Ltd. | 2020-08-07 |
| TaiChiA (K193207) | Our United Corporation | 2020-08-07 |
| VIDAvision (K200990) | Vida Diagnostics, Inc. | 2020-08-07 |
| Midmark Extraoral Imaging System (EOIS) (K201667) | Midmark Corporation | 2020-08-06 |
| XBit Series Digital Color Doppler Ultrasound System (K200780) | CHISON Medical Technologies Co., Ltd. | 2020-08-05 |
| HYPER DLR (K193210) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-08-04 |
| Glaucoma Module (K200954) | Topcon Healthcare Solutions, Inc. | 2020-08-03 |
| Liver Incytes, Model 1005 (K201597) | Sonic Incytes | 2020-07-31 |
| Clear Guide SCENERGY (K201898) | Clear Guide Medical | 2020-07-31 |
| AI-Rad Companion Prostate MR (K193283) | Siemens Medical Solutions USA, Inc. | 2020-07-30 |
| S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059) | Sonoscape Medical Corp. | 2020-07-30 |
| FractureDetect (FX) (K193417) | Imagen Technologies, Inc. | 2020-07-30 |
| SyMRI (K201616) | Syntheticmr AB | 2020-07-28 |
| Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous (K200643) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-07-24 |
| JUSHA-CP610 LCD Monitor (K200742) | Nanjing Jusha Display Technology Co., Ltd. | 2020-07-24 |
| 1717SCV, 1717SGV (K201796) | Rayence Co., Ltd. | 2020-07-23 |
| Vivid E80/ Vivid E90/ Vivid E95 (K200743) | Ge Medical Systems Ultrasound And | 2020-07-23 |
| SOMATOM On.site and On.scene (K193277) | Siemens Medical Solutions USA, Inc. | 2020-07-22 |
| 8ch Flex Suite (K200836) | Shenzhen RF Tech Co., Ltd. | 2020-07-22 |
| Caption Interpretation Automated Ejection Fraction Software (K200621) | Caption Health | 2020-07-22 |
| SuRgical Planner (SRP) BrainStorm (K201465) | Surgical Theater, Inc. | 2020-07-17 |
| myQA iON (K201798) | Iba Dosimetry GmbH | 2020-07-17 |
| True 3D Viewer (K201365) | Echopixel, Inc. | 2020-07-17 |
| Rover (K201488) | Micro-X , Ltd. | 2020-07-17 |
| SCENARIA View (K200498) | Hitachi Healthcare Americas | 2020-07-17 |
| Vivid S60N, Vivid S70N (K200497) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-07-16 |
| FibroScan® 630 (K200655) | Echosens | 2020-07-16 |
| Geneva (K201272) | Nucletron B.V. | 2020-07-16 |
| HealthMammo (K200905) | Zebra Medical Vision, Ltd. | 2020-07-16 |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K193097) | Canon Medical Systems Corporation | 2020-07-14 |
| ExacTrac Dynamic (K201276) | Brainlab AG | 2020-07-13 |
| Digiscan FDX (K200218) | Allengers Medical Systems Limited | 2020-07-13 |
| PROBEAT-CR (K201042) | Hitachi , Ltd. | 2020-07-13 |
| X-Cube 70 (K200450) | Alpinion Medical Systems Co., Ltd. | 2020-07-10 |
| Resoundant Acoustic Driver System (K201389) | Resoundant, Inc. | 2020-07-10 |
| DigitalDiagnost C50 (K201725) | Philips Healthcare (Suzhou) Co., Lit. | 2020-07-10 |
| Eclipse Treatment Planning System v16.1 (K201607) | Varian Medical Systems, Inc. | 2020-07-10 |
| X-Cube 90 (K200449) | Alpinion Medical Systems Co., Ltd. | 2020-07-10 |
| AI-Rad Companion Engine (K193294) | Siemens Medical Solutions USA, Inc. | 2020-07-10 |
| ASSISTO Universal Applicator Clamping Device (K201279) | Geomed Medizin-Technik GmbH & Co. KG | 2020-07-10 |
| Ezra Plexo Software (K192969) | Ezra Ai, Inc. | 2020-07-10 |
| XACT Robotic System (K201586) | Xact Robotics, Ltd. | 2020-07-09 |
| SR-8100 Portable X-ray Unit (K200637) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-07-09 |
| i-Rapha Solution (K201296) | Irm, Inc. | 2020-07-09 |
| DuraDiagnost (K201640) | Philips Healthcare (Suzhou) Co., Ltd. | 2020-07-09 |
| Rapid LVO (K200941) | Ischemaview, Inc. | 2020-07-09 |
| CMDR 2C (Multiple Models) (K201575) | Minxray, Inc. | 2020-07-08 |
| uMR570 (K201540) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 |
| Deep Recon (K193073) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 |
| Lollipop BiteBlock (K200652) | Radtec Medical Devices, Inc. | 2020-07-06 |
| 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ (K201599) | Shenzhen Beacon Display Technology Co., Ltd. | 2020-07-02 |
| Contour ProtegeAI (K193252) | Mim Software, Inc. | 2020-07-02 |
| Terason uSmart 3200T Plus Ultrasound System (K201633) | Teratech Corporation | 2020-07-02 |
| InferRead Lung CT.AI (K192880) | Beijing Infervision Technology Co., Ltd. | 2020-07-02 |
| Versana Premier (K200138) | Ge Medical Systems Ultrasound And | 2020-07-01 |
| syngo.via View&GO (K201477) | Siemens Healthcare GmbH | 2020-07-01 |
| ARTIS pheno (VE2) (K201156) | Siemens Medical Solution USA, Inc. | 2020-06-29 |
| Edge Air(1417) Digital Flat Panel X-ray Detector (K201503) | Osko, Inc. | 2020-06-29 |
| DRX-Compass (K201373) | Carestream Health, Inc. | 2020-06-26 |
| Rapid ASPECTS (K200760) | Ischemaview, Inc. | 2020-06-26 |
| Optimized Positioning System (OPS) ReView (K193042) | Corin USA | 2020-06-26 |
| ChartCheck (K201119) | Radformation, Inc. | 2020-06-26 |
| ACUSON Sequoia Diagnostic Ultrasound System (K201462) | Siemens Medical Solutions USA, Inc. | 2020-06-24 |
| CINA (K200855) | Avicenna.Ai | 2020-06-24 |
| ControlRad Trace Model 9 (K200663) | Controlrad, Inc. | 2020-06-24 |
| LVivo Software Application (K200232) | Dia Imaging Analysis, Ltd. | 2020-06-23 |
| Axeos (K201140) | Dentsply Sirona | 2020-06-22 |
| AQUILA 320 D / AQUILA 320 S (K201340) | Vmi Tecnologias Ltda | 2020-06-19 |
| BriefCase (K193298) | Aidoc Medical , Ltd. | 2020-06-19 |
| Giotto Class (Models - 3000X-YY and 4000X-YY) (K200424) | Ims Giotto S.P.A. | 2020-06-18 |
| AI-Rad Companion Brain MR (K193290) | Siemens Medical Solutions USA, Inc. | 2020-06-17 |
| qER (K200921) | Qure.Ai Technologies | 2020-06-17 |
| Quantib AI Node (K200899) | Quantib B.V. | 2020-06-15 |
| Kubtec Mozart Supra (K200756) | Kub Technologies, Inc. | 2020-06-12 |
| MAMMOMAT Revelation (K193166) | Siemens Medical Solutions USA, Inc. | 2020-06-12 |
| Versana Active (K200998) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-06-11 |
| MEDO ARIA (K200356) | Medo.Ai | 2020-06-11 |
| Gold Anchor (K201117) | Naslund Medical AB | 2020-06-11 |
| uWS-MI (K192630) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-06-11 |
| Auto 3D Bladder Volume Tool (K200980) | Butterfly Network, Inc. | 2020-06-11 |
| SR-8230, SR-8230S Portable X-ray Unit (K200976) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-06-10 |
| RayCare 3.1 (K200487) | RaySearch Laboratories AB (PUBL) | 2020-06-10 |
| Intraoral Sensor (K201247) | Dentium Co., Ltd (Ict Branch) | 2020-06-10 |
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Every clearance here is in the API, with alerts when new ones post.