Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 26
- Latest Decision
- 2022-05-03
Clearances · page 21 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K212915 | MVision AI Segmentation | MVision AI | QKB | Class II | 2022-05-03 |
| K211180 | Liver Suite | GE Medical Systems SCS | JAK | Class II | 2022-05-02 |
| K220271 | Hand Diagnostic Radiography Imaging System | Nanoray Biotech Co., Ltd. | KPR | Class II | 2022-04-29 |
| K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-04-29 |
| K220684 | Oryx Cloud Imaging | Oryx Dental Software, Inc. | LLZ | Class II | 2022-04-29 |
| K220338 | ExacTrac Dynamic | Brainlab AG | IYE | Class II | 2022-04-29 |
| K211350 | Bindex BI-2 | Bone Index Finland , Ltd. | MUA | Class II | 2022-04-29 |
| K220295 | ARIETTA 50 | Fujifilm Healthcare Corporation | IYN | Class II | 2022-04-29 |
| K220590 | aPROMISE X | Exini Diagnostics AB | LLZ | Class II | 2022-04-29 |
| K213649 | BodyTom 64 | Neurologica Corporation | JAK | Class II | 2022-04-29 |
| K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | QKB | Class II | 2022-04-28 |
| K220536 | Digital flat panel detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-04-28 |
| K211713 | AngioCloud Service | Angiocloud, LLC | LLZ | Class II | 2022-04-28 |
| K211715 | RetinAI Discovery | Retinai Medical AG | NFJ | Class II | 2022-04-28 |
| K213278 | Planmed Verity | Planmed OY | OAS | Class II | 2022-04-28 |
| K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2022-04-27 |
| K213886 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-04-26 |
| K212400 | SONON Ultrasound Imaging System, Model: SONON 500L | Healcerion Co., Ltd. | IYN | Class II | 2022-04-22 |
| K213620 | ATUSA Automated 3D Breast Ultrasound System | Isono Health, Inc. | IYO | Class II | 2022-04-22 |
| K213944 | HealthOST | Nanoxai , Ltd. | JAK | Class II | 2022-04-22 |
| K212981 | MirrorMe3D Modeling System | Mirrorme3D, LLC | LLZ | Class II | 2022-04-22 |
| K213795 | Videa Caries Assist | Videahealth, Inc. | MYN | Class II | 2022-04-21 |
| K220175 | GM85 | Samsung Electronics Co., Ltd. | IZL | Class II | 2022-04-21 |
| K220149 | General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) | Xera Medical Systems & Technology , Ltd. | KPR | Class II | 2022-04-19 |
| K220871 | Nautilus | Dornier Medtech America, Inc. | JAA | Class II | 2022-04-18 |
| K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2022-04-15 |
| K213706 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | QIH | Class II | 2022-04-15 |
| K220946 | SURGIVISIO Device | Ecential Robotics | OWB | Class II | 2022-04-15 |
| K220779 | XD | Mirada Medical, Ltd. | LLZ | Class II | 2022-04-15 |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | MQB | Class II | 2022-04-14 |
| K220767 | TeleScan | Bb Imaging | LLZ | Class II | 2022-04-14 |
| K212274 | INT Contour | Carina Medical, LLC | MUJ | Class II | 2022-04-08 |
| K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2022-04-08 |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | Noras Mri Products GmbH | MOS | Class II | 2022-04-08 |
| K220490 | ImaCor Zura Handheld ZHH-010 | Imacor, Inc. | IYN | Class II | 2022-04-08 |
| K203783 | ClariPulmo | Claripi, Inc. | LLZ | Class II | 2022-04-06 |
| K214081 | MRCAT Head & Neck | Philips OY | MUJ | Class II | 2022-04-05 |
| K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2022-04-05 |
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2022-04-05 |
| K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | QIH | Class II | 2022-04-04 |
| K220518 | SKANRAD 400 | Skanray Technologies Limited | KPR | Class II | 2022-04-01 |
| K220668 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-04-01 |
| K220151 | MAGNETOM Avanto Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-04-01 |
| K220678 | APX-24 Portable X-ray System | Aspenstate, Inc. | IZL | Class II | 2022-03-31 |
| K213370 | VERIQA | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | IYE | Class II | 2022-03-30 |
| K212159 | Shield System | Radiaction , Ltd. | OWB | Class II | 2022-03-30 |
| K214093 | VSP Bolus | 3D Systems | IXI | Class II | 2022-03-30 |
| K213529 | Focus HD 43 Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-03-29 |
| K213646 | Focus HD 35 Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2022-03-29 |
| K212889 | Syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-03-28 |
| K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | LLZ | Class II | 2022-03-25 |
| K212231 | C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2022-03-25 |
| K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2022-03-25 |
| K213568 | DRX-Rise Mobile X-ray System | Carestream Health | IZL | Class II | 2022-03-23 |
| K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | IYN | Class II | 2022-03-22 |
| K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2022-03-22 |
| K213721 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2022-03-21 |
| K220627 | SURGIVISIO Device | Ecential Robotics | OWB | Class II | 2022-03-18 |
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | IYO | Class II | 2022-03-16 |
| K213779 | Customize | 3D-Side S.A. | QIH | Class II | 2022-03-16 |
| K203744 | Arterys MICA | Arterys, Inc. | QIH | Class II | 2022-03-14 |
| K214043 | BriefCase | Aidoc Medical , Ltd. | QFM | Class II | 2022-03-14 |
| K220425 | MAGNETOM Vida, MAGNETOM Sola | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-03-11 |
| K212040 | RI.HIP MODELER | Blue Belt Technologies, Inc. | LLZ | Class II | 2022-03-11 |
| K213687 | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch | Neocoil, LLC | MOS | Class II | 2022-03-11 |
| K213725 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | 2022-03-11 |
| K213566 | ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | QFM | Class II | 2022-03-10 |
| K211780 | ZEN-2090 Turbo | Genoray Co., Ltd. | OWB | Class II | 2022-03-09 |
| K220450 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-03-07 |
| K220051 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2022-03-04 |
| K210365 | Second Opinion | Pearl, Inc. | MYN | Class II | 2022-03-04 |
| K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | IZL | Class II | 2022-03-04 |
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T | Noras Mri Products GmbH | MOS | Class II | 2022-03-03 |
| K212720 | nordicDSC | Nordicneurolab AS | LLZ | Class II | 2022-03-03 |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei | Philips Medical Systems Nederland B.V. | LNH | Class II | 2022-03-03 |
| K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | LNH | Class II | 2022-03-03 |
| K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | OAS | Class II | 2022-03-02 |
| K213279 | NovaGuide 2 Intelligent Ultrasound | Novasignal Corporation | IYN | Class II | 2022-03-02 |
| K210151 | Digimamo D | Vmi Tecnologias Ltda | MUE | Class II | 2022-03-01 |
| K212365 | BoneView | Gleamer | QBS | Class II | 2022-03-01 |
| K214097 | Explorer Air II | Surgvision GmbH | IZI | Class II | 2022-02-25 |
| K211711 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | 2022-02-25 |
| K213693 | MAGNETOM Vida with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2022-02-25 |
| K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | QFM | Class II | 2022-02-24 |
| K211645 | Epione | Quantum Surgical Sas | JAK | Class II | 2022-02-24 |
| K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2022-02-23 |
| K212212 | Multitom Rax with True2scale Body Scan Option | Siemens Medical Solutions | OWB | Class II | 2022-02-18 |
| K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | QFM | Class II | 2022-02-18 |
| K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | JAK | Class II | 2022-02-18 |
| K211746 | Pocket Ultrasound System | Guangdong Youkey Medical Co., Ltd. | IYN | Class II | 2022-02-18 |
| K213057 | ExamVue Duo | Jpi Healthcare Co, Ltd. | KPR | Class II | 2022-02-18 |
| K213689 | Voluson P6, Voluson P8 | GE Healthcare | IYN | Class II | 2022-02-17 |
| K214044 | 14HQ901G-B | Lg Electronics.Inc | MQB | Class II | 2022-02-16 |
| K213462 | EzRay M18 (Model: VMX-P400) | VATECH Co., Ltd. | IZL | Class II | 2022-02-11 |
| K213603 | SIGNA Artist Evo | Ge Healthcare (Tianjin) Company Limited | LNH | Class II | 2022-02-11 |
| K213487 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2022-02-11 |
| K211248 | ArtUs | Telemed | IYN | Class II | 2022-02-11 |
| K213165 | Rapid | Ischemaview, Inc. | LLZ | Class II | 2022-02-08 |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | MQB | Class II | 2022-02-04 |
| K212654 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | IZL | Class II | 2022-02-04 |
14,721 clearances in the Radiology panel. Data: openFDA.