Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2020-07-30
Clearances · page 28 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2020-07-30 |
| K201616 | SyMRI | Syntheticmr AB | LNH | Class II | 2020-07-28 |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-07-24 |
| K200742 | JUSHA-CP610 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2020-07-24 |
| K201796 | 1717SCV, 1717SGV | Rayence Co., Ltd. | MQB | Class II | 2020-07-23 |
| K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And | IYN | Class II | 2020-07-23 |
| K200836 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | MOS | Class II | 2020-07-22 |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | QIH | Class II | 2020-07-22 |
| K193277 | SOMATOM On.site and On.scene | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2020-07-22 |
| K201798 | myQA iON | Iba Dosimetry GmbH | LHN | Class II | 2020-07-17 |
| K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | LLZ | Class II | 2020-07-17 |
| K200498 | SCENARIA View | Hitachi Healthcare Americas | JAK | Class II | 2020-07-17 |
| K201365 | True 3D Viewer | Echopixel, Inc. | LLZ | Class II | 2020-07-17 |
| K201488 | Rover | Micro-X , Ltd. | IZL | Class II | 2020-07-17 |
| K200905 | HealthMammo | Zebra Medical Vision, Ltd. | QFM | Class II | 2020-07-16 |
| K200655 | FibroScan® 630 | Echosens | IYO | Class II | 2020-07-16 |
| K201272 | Geneva | Nucletron B.V. | JAQ | Class II | 2020-07-16 |
| K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-07-16 |
| K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2020-07-14 |
| K200218 | Digiscan FDX | Allengers Medical Systems Limited | OWB | Class II | 2020-07-13 |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | LHN | Class II | 2020-07-13 |
| K201276 | ExacTrac Dynamic | Brainlab AG | IYE | Class II | 2020-07-13 |
| K201607 | Eclipse Treatment Planning System v16.1 | Varian Medical Systems, Inc. | MUJ | Class II | 2020-07-10 |
| K193294 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2020-07-10 |
| K192969 | Ezra Plexo Software | Ezra Ai, Inc. | QIH | Class II | 2020-07-10 |
| K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | JAQ | Class II | 2020-07-10 |
| K200450 | X-Cube 70 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2020-07-10 |
| K200449 | X-Cube 90 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2020-07-10 |
| K201389 | Resoundant Acoustic Driver System | Resoundant, Inc. | LNH | Class II | 2020-07-10 |
| K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | KPR | Class II | 2020-07-10 |
| K201586 | XACT Robotic System | Xact Robotics, Ltd. | JAK | Class II | 2020-07-09 |
| K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | 2020-07-09 |
| K200941 | Rapid LVO | Ischemaview, Inc. | QAS | Class II | 2020-07-09 |
| K201296 | i-Rapha Solution | Irm, Inc. | LLZ | Class II | 2020-07-09 |
| K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | KPR | Class II | 2020-07-09 |
| K201575 | CMDR 2C (Multiple Models) | Minxray, Inc. | IZL | Class II | 2020-07-08 |
| K200652 | Lollipop BiteBlock | Radtec Medical Devices, Inc. | IYE | Class II | 2020-07-06 |
| K201540 | uMR570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2020-07-06 |
| K193073 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2020-07-06 |
| K201599 | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2020-07-02 |
| K201633 | Terason uSmart 3200T Plus Ultrasound System | Teratech Corporation | IYN | Class II | 2020-07-02 |
| K193252 | Contour ProtegeAI | Mim Software, Inc. | QKB | Class II | 2020-07-02 |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | OEB | Class II | 2020-07-02 |
| K200138 | Versana Premier | Ge Medical Systems Ultrasound And | IYN | Class II | 2020-07-01 |
| K201477 | syngo.via View&GO | Siemens Healthcare GmbH | LLZ | Class II | 2020-07-01 |
| K201503 | Edge Air(1417) Digital Flat Panel X-ray Detector | Osko, Inc. | MQB | Class II | 2020-06-29 |
| K201156 | ARTIS pheno (VE2) | Siemens Medical Solution USA, Inc. | OWB | Class II | 2020-06-29 |
| K193042 | Optimized Positioning System (OPS) ReView | Corin USA | LLZ | Class II | 2020-06-26 |
| K200760 | Rapid ASPECTS | Ischemaview, Inc. | POK | Class II | 2020-06-26 |
| K201119 | ChartCheck | Radformation, Inc. | IYE | Class II | 2020-06-26 |
| K201373 | DRX-Compass | Carestream Health, Inc. | KPR | Class II | 2020-06-26 |
| K200855 | CINA | Avicenna.Ai | QAS | Class II | 2020-06-24 |
| K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-06-24 |
| K200663 | ControlRad Trace Model 9 | Controlrad, Inc. | OWB | Class II | 2020-06-24 |
| K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | 2020-06-23 |
| K201140 | Axeos | Dentsply Sirona | OAS | Class II | 2020-06-22 |
| K201340 | AQUILA 320 D / AQUILA 320 S | Vmi Tecnologias Ltda | IZL | Class II | 2020-06-19 |
| K193298 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2020-06-19 |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | MUE | Class II | 2020-06-18 |
| K200921 | qER | Qure.Ai Technologies | QAS | Class II | 2020-06-17 |
| K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2020-06-17 |
| K200899 | Quantib AI Node | Quantib B.V. | LLZ | Class II | 2020-06-15 |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | MWP | Class II | 2020-06-12 |
| K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | MUE | Class II | 2020-06-12 |
| K192630 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2020-06-11 |
| K200356 | MEDO ARIA | Medo.Ai | QIH | Class II | 2020-06-11 |
| K200998 | Versana Active | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-06-11 |
| K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | IYO | Class II | 2020-06-11 |
| K201117 | Gold Anchor | Naslund Medical AB | IYE | Class II | 2020-06-11 |
| K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | MQB | Class II | 2020-06-10 |
| K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2020-06-10 |
| K200976 | SR-8230, SR-8230S Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | 2020-06-10 |
| K191491 | EZ-Cover | Medxpress.Pro | ITX | Class II | 2020-06-05 |
| K200974 | QLAB Advanced Quantification Software | Philips Health Care | QIH | Class II | 2020-06-03 |
| K193021 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | LNH | Class II | 2020-06-03 |
| K200907 | Thales 3D Mr Scanner | Lap GmbH Laser Applikationen | IYE | Class II | 2020-06-03 |
| K200889 | iMac 27 & PL 4.0 | Quantum-Spectra, LLC | PGY | Class II | 2020-06-02 |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | Neocoil, LLC | MOS | Class II | 2020-06-02 |
| K201202 | MI View&GO | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2020-06-02 |
| K192601 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | 2020-06-01 |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | KXK | Class II | 2020-05-29 |
| K201172 | CFP-3131, CFP-2222 | Mx Imaging, Inc. | OWB | Class II | 2020-05-29 |
| K192692 | Brainomix 360 e-CTA | Brainomix Limited | LLZ | Class II | 2020-05-28 |
| K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-05-28 |
| K201130 | ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-05-26 |
| K200944 | UNIEXPERT 2 PLUS | Adani | KPR | Class II | 2020-05-26 |
| K200274 | CariCloud | Caristo Diagnostics | LLZ | Class II | 2020-05-21 |
| K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | 2020-05-21 |
| K200864 | 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2020-05-19 |
| K200749 | CUBEScan BioCon-900S | Mcube Technology Co., Ltd. | IYO | Class II | 2020-05-19 |
| K201124 | TOPAZ Mobile DR System | DRGEM Corporation | IZL | Class II | 2020-05-19 |
| K201062 | syngo Ultrasound Apps Suite (sUSAS) | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2020-05-18 |
| K193334 | Pristina Serena Bright | GE Healthcare | MUE | Class II | 2020-05-15 |
| K193293 | XV Lung Ventilation Analysis Software | 4Dx Limited | JAK | Class II | 2020-05-14 |
| K201053 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | JAK | Class II | 2020-05-14 |
| K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2020-05-14 |
| K192901 | HealthVCF | Zebra Medical Vision, Ltd. | QFM | Class II | 2020-05-12 |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang , Ltd. | MQB | Class II | 2020-05-12 |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | OUO | Class II | 2020-05-11 |
| K200964 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2020-05-08 |
14,721 clearances in the Radiology panel. Data: openFDA.