Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 26
- Latest Decision
- 2020-10-30
Clearances · page 27 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200323 | AutoContour | Radformation, Inc. | QKB | Class II | 2020-10-30 |
| K201092 | LSN | Imaging Biometrics, LLC | JAK | Class II | 2020-10-29 |
| K203058 | CloudVue | International Medical Solutions, Inc. | LLZ | Class II | 2020-10-29 |
| K201627 | Dental Computed Tomography X-Ray System, Green X | VATECH Co., Ltd. | OAS | Class II | 2020-10-27 |
| K202519 | OrthoNext Platform System | Orthofix Srl | LLZ | Class II | 2020-10-27 |
| K202722 | 1212FCA | Rayence Co., Ltd. | MQB | Class II | 2020-10-26 |
| K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | MUE | Class II | 2020-10-23 |
| K202392 | SIR-Spheres Microspheres Activity Calculator (SMAC) | Sirtex Medical US Holdings, Inc. | KPS | Class II | 2020-10-23 |
| K201768 | Voluson E10 | GE Healthcare | IYN | Class II | 2020-10-22 |
| K202948 | EzOrtho | Ewoosoft Co., Ltd. | LLZ | Class II | 2020-10-22 |
| K202030 | OASIS MRI System | Hitachi Healthcare Americas | LNH | Class II | 2020-10-21 |
| K201670 | YSIO X.pree | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2020-10-21 |
| K202374 | 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2020-10-19 |
| K201710 | A View LCS | Coreline Soft Co., Ltd. | LLZ | Class II | 2020-10-16 |
| K202737 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2020-10-16 |
| K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2020-10-15 |
| K202349 | Cartesion Prime, PCD-1000A, V10.7 | Canon Medical Systems Corporation | KPS | Class II | 2020-10-15 |
| K201615 | SIGNA 7.0T | Ge Medical Systems, LLC | LNH | Class II | 2020-10-15 |
| K202364 | Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | IYN | Class II | 2020-10-15 |
| K201828 | Voluson SWIFT, Voluson SWIFT+ | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-10-11 |
| K202501 | Quantib Prostate | Quantib B.V. | LLZ | Class II | 2020-10-11 |
| K202213 | syngo.CT Neuro Perfusion | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2020-10-11 |
| K201528 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | MQB | Class II | 2020-10-11 |
| K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | IYN | Class II | 2020-10-08 |
| K200810 | IPS CaseDesigner | Nobel Biocare AB | LLZ | Class II | 2020-10-08 |
| K201777 | 31HN713D | Lg Electronics.Inc | PGY | Class II | 2020-10-08 |
| K202293 | Radiographic System Challenge X | Sedecal., Sa. | KPR | Class II | 2020-10-07 |
| K202119 | AcuSee AS-P1000 System | Weipeng (Suzhou) Medical Devices Co., Ltd. | IYO | Class II | 2020-10-07 |
| K202292 | UDE | Ebm Technologies, Inc. | LLZ | Class II | 2020-10-05 |
| K202294 | Affirm Contrast Biopsy | Hologic, Inc. | IZH | Class II | 2020-10-05 |
| K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | LLZ | Class II | 2020-10-02 |
| K202170 | LiverMultiScan | Perspectum, Ltd. | LNH | Class II | 2020-10-02 |
| K201928 | e-Ortho Shoulder Software | FH Industrie | LLZ | Class II | 2020-09-30 |
| K201188 | Clear Guide SCENERGY | Clear Guide Medical | JAK | Class II | 2020-09-30 |
| K192051 | THINQ | Corticometrics, LLC | LLZ | Class II | 2020-09-30 |
| K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | MQB | Class II | 2020-09-30 |
| K202546 | LVivo Seamless | Dia Imaging Analysis, Ltd. | QIH | Class II | 2020-09-29 |
| K201103 | Xeleris V Processing and Review Systems | GE Healthcare | LLZ | Class II | 2020-09-25 |
| K201273 | ImageSPECTRUM | Canon, Inc. | NFJ | Class II | 2020-09-25 |
| K200569 | RayStation | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2020-09-24 |
| K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | KPR | Class II | 2020-09-24 |
| K202210 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | LNH | Class II | 2020-09-22 |
| K201350 | CORVUS | Best Nomos | MUJ | Class II | 2020-09-20 |
| K200603 | AAA Model | Philips Ultrasound, Inc. | LLZ | Class II | 2020-09-20 |
| K192890 | SentEP | Sentiar, Inc. | LLZ | Class II | 2020-09-18 |
| K201992 | Caption Guidance | Caption Health | QJU | Class II | 2020-09-18 |
| K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | LLZ | Class II | 2020-09-18 |
| K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | IYN | Class II | 2020-09-16 |
| K202360 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | OWB | Class II | 2020-09-16 |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | OAS | Class II | 2020-09-16 |
| K201369 | AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte, Ltd. | LLZ | Class II | 2020-09-16 |
| K202394 | EOSedge | Eos Imaging | KPR | Class II | 2020-09-16 |
| K201665 | Collaboration Live | Philips Ultrasound, Inc. | LLZ | Class II | 2020-09-15 |
| K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | LLZ | Class II | 2020-09-11 |
| K202156 | DIAMOND-5A/6A/8A | DRGEM Corporation | KPR | Class II | 2020-09-10 |
| K200708 | Vivid iq | Ge Medical Systems Ultrasound And | IYN | Class II | 2020-09-09 |
| K201948 | AcroDTI Visualizer | Acroviz, Inc. | LLZ | Class II | 2020-09-09 |
| K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2020-09-09 |
| K202256 | 3Shape Implant Studio | 3Shape Medical A/S | LLZ | Class II | 2020-09-09 |
| K202014 | Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2020-09-08 |
| K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | LLZ | Class II | 2020-09-04 |
| K202238 | SIGNA Artist | Ge Healthcare (Tianjin) Company Limited | LNH | Class II | 2020-09-04 |
| K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2020-09-03 |
| K201591 | Flat Panel Detector | Ka Imaging, Inc. | MQB | Class II | 2020-09-03 |
| K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | JAA | Class II | 2020-09-03 |
| K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | IYN | Class II | 2020-09-02 |
| K201552 | ApolloVue S100 Image System | Apollo Medical Optics, Ltd. | NQQ | Class II | 2020-09-02 |
| K200916 | Patient Administration Set | Cyclomedica Australia Pty, Ltd. | IYT | Class II | 2020-09-01 |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2020-09-01 |
| K202224 | SpaceOAR System | Boston Scientific Corporation | OVB | Class II | 2020-08-28 |
| K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | LLZ | Class II | 2020-08-27 |
| K201807 | ANCORIS | Miegmbh | KPS | Class II | 2020-08-27 |
| K201020 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2020-08-26 |
| K200714 | AVIEW | Coreline Soft Co., Ltd. | LLZ | Class II | 2020-08-26 |
| K201141 | FIRMM | Nous Imaging, Inc. | LNH | Class II | 2020-08-26 |
| K201693 | 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 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2020-08-21 |
| K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | LLZ | Class II | 2020-08-21 |
| K202050 | Cranial 4Pi Immobilization | Brainlab AG | IYE | Class II | 2020-08-19 |
| K201995 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | IYO | Class II | 2020-08-19 |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | JAQ | Class II | 2020-08-17 |
| K201352 | 3D Auto LAA | Philips Health Care | LLZ | Class II | 2020-08-17 |
| K201632 | TOMTEC-ARENA | Tomtec Imaging Systems GmbH | LLZ | Class II | 2020-08-14 |
| K202068 | The AIO Solution 3.0 | Orfit Industries NV | IYE | Class II | 2020-08-14 |
| K201232 | Limbus Contour | Limbus Ai, Inc. | LLZ | Class II | 2020-08-13 |
| K200822 | Braid | Braid.Health | LLZ | Class II | 2020-08-13 |
| K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2020-08-13 |
| K201933 | ImagenSPECT 3.0 | Cardiovascular Imaging Technologies | KPS | Class II | 2020-08-11 |
| K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | LNH | Class II | 2020-08-11 |
| K201310 | Accipiolx | Maxq AL , Ltd. | QAS | Class II | 2020-08-07 |
| K193207 | TaiChiA | Our United Corporation | IYE | Class II | 2020-08-07 |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | Careray Digital Medical System Co., Ltd. | MQB | Class II | 2020-08-07 |
| K200990 | VIDAvision | Vida Diagnostics, Inc. | JAK | Class II | 2020-08-07 |
| K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corporation | OAS | Class II | 2020-08-06 |
| K200780 | XBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2020-08-05 |
| K193210 | HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2020-08-04 |
| K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | NFJ | Class II | 2020-08-03 |
| K201597 | Liver Incytes, Model 1005 | Sonic Incytes | IYO | Class II | 2020-07-31 |
| K201898 | Clear Guide SCENERGY | Clear Guide Medical | JAK | Class II | 2020-07-31 |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | QBS | Class II | 2020-07-30 |
| K193283 | AI-Rad Companion Prostate MR | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2020-07-30 |
14,721 clearances in the Radiology panel. Data: openFDA.