Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 29
- Latest Decision
- 2022-02-04
Clearances · page 22 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K214062 | Radialis PET Camera | Radialis, Inc. | KPS | Class II | 2022-02-04 |
| K212419 | Magnifico Open, Magnifico MSK | Esaote, S.p.A. | LNH | Class II | 2022-02-04 |
| K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | JAK | Class II | 2022-02-04 |
| K213801 | Veuron-Brain-pAb2 | Heuron Co., Ltd. | LLZ | Class II | 2022-02-04 |
| K212271 | smart-sync | Northh Medical GmbH | LNH | Class II | 2022-02-04 |
| K213976 | Contour ProtégéAI | Mim Software, Inc. | QKB | Class II | 2022-02-03 |
| K213908 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2022-01-31 |
| K203260 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | QAS | Class II | 2022-01-28 |
| K213523 | X-CUBE i8, X-CUBE i9 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2022-01-28 |
| K212373 | Sim&Size | Sim&Cure | PZO | Class II | 2022-01-27 |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | Canon, Inc. | MQB | Class II | 2022-01-24 |
| K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | IYN | Class II | 2022-01-24 |
| K214030 | Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. | MQB | Class II | 2022-01-21 |
| K213709 | SIGNA PET/MR | Ge Medical Systems, LLC | OUO | Class II | 2022-01-20 |
| K213668 | SIGNA Hero | Ge Healthcare (Ge Medical Systems, LLC) | LNH | Class II | 2022-01-20 |
| K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2022-01-20 |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS | Class II | 2022-01-20 |
| K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory | Adaptiiv | MUJ | Class II | 2022-01-19 |
| K212012 | Follicle Clarity | Cycle Clarity | QIH | Class II | 2022-01-19 |
| K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | QIH | Class II | 2022-01-19 |
| K211980 | SIGNA Prime | Ge Healthcare (Tianjin) Company Limited | LNH | Class II | 2022-01-16 |
| K210760 | Precise Image | Philips Medical Systems Nederland B.V. | JAK | Class II | 2022-01-14 |
| K213307 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | MQB | Class II | 2022-01-14 |
| K213927 | Respiratory Gating for Scanners v2.0 | Varian Medical Systems, Inc. | JAK | Class II | 2022-01-14 |
| K213737 | Quantib ND | Quantib B.V. | LLZ | Class II | 2022-01-14 |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | GE Healthcare | IYN | Class II | 2022-01-13 |
| K214012 | Straight Arm DDR | Konica Minolta Healthcare Americas, Inc. | KPR | Class II | 2022-01-12 |
| K212005 | UNiD Spine Analyzer | Medicrea International, Inc. | LLZ | Class II | 2022-01-12 |
| K213102 | ES1 System | E-Scopics | IYN | Class II | 2022-01-11 |
| K213942 | Esteya | Nucletron B.V. | JAD | Class II | 2022-01-11 |
| K211443 | AIBOLIT 3D+ | Aibolit Technologies, LLC | LLZ | Class II | 2022-01-07 |
| K213053 | Gold Anchor | Naslund Medical AB | IYE | Class II | 2022-01-06 |
| K213544 | TOMTEC-ARENA | Tomtec Imaging Systems GmbH | QIH | Class II | 2022-01-06 |
| K210830 | VUZE System | Vuze Medical , Ltd. | LLZ | Class II | 2022-01-03 |
| K211159 | eco-x Series (eco-x, eco-x-s) | Hdx Will Corp. | OAS | Class II | 2021-12-30 |
| K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | LLZ | Class II | 2021-12-29 |
| K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | PCS | Class II | 2021-12-29 |
| K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2021-12-27 |
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | Invivo Corporation | MOS | Class II | 2021-12-23 |
| K213479 | D²RS and D²RS 9090 | Stephanix | OWB | Class II | 2021-12-23 |
| K213411 | iSRobot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | IYO | Class II | 2021-12-22 |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | MWP | Class II | 2021-12-22 |
| K211691 | Ultrast Gel | Ultrast, Inc. | MUI | Class II | 2021-12-22 |
| K202404 | BoneMRI | Mriguidance B.V. | QIH | Class II | 2021-12-22 |
| K213140 | Claritas iPET | Claritas Healthtech Pte, Ltd. | LLZ | Class II | 2021-12-22 |
| K212690 | qXR-BT | Qure.Ai Technologies | QIH | Class II | 2021-12-21 |
| K210670 | BU-CAD | Taihao Medical, Inc. | QDQ | Class II | 2021-12-21 |
| K213275 | EchoGo Core (2.0) | Ultromics Limited | QIH | Class II | 2021-12-20 |
| K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | MOS | Class II | 2021-12-17 |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition | Ge Medical Systems, LLC | JAK | Class II | 2021-12-17 |
| K210931 | Libby IAAA v1.0 | Dyad Medical, Inc. | LLZ | Class II | 2021-12-17 |
| K213628 | VBrain | Vysioneer, Inc. | QKB | Class II | 2021-12-16 |
| K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio | Brainlab AG | LLZ | Class II | 2021-12-16 |
| K212985 | 6MP Color LCD Monitor CL-S600 | Jvckenwood Corporation | PGY | Class II | 2021-12-16 |
| K212616 | Koios DS | Koios Medical, Inc. | POK | Class II | 2021-12-16 |
| K213155 | RT-Mind-AI | Medmind Technology Co., Ltd. | QKB | Class II | 2021-12-15 |
| K202822 | Helianthus | Metaltronica Spa | MUE | Class II | 2021-12-15 |
| K211803 | HealthPPT | Zebra Medical Vision, Ltd. | QFM | Class II | 2021-12-15 |
| K211114 | Will3D | Hdx Will Corp. | LLZ | Class II | 2021-12-15 |
| K211039 | BIT-Motion | Dde Mri Solutions, Ltd. | LLZ | Class II | 2021-12-15 |
| K212958 | MRIdian Linac System | Viewray, Incorporated | IYE | Class II | 2021-12-14 |
| K213700 | MULTIX Impact, MULTIX Impact C | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2021-12-13 |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | JAA | Class II | 2021-12-13 |
| K212186 | Philips Radiology Smart Assistant | Philips Medical Systems Dmc GmbH | KPR | Class II | 2021-12-13 |
| K203743 | EXA | Konica Minolta Healthcare Americas, Inc. | LLZ | Class II | 2021-12-10 |
| K212137 | X-Clever | Lg Electronics.Inc | LLZ | Class II | 2021-12-10 |
| DEN200041 | Comfort Marker 2.0. | Medical Precision BV | QRN | Class II | 2021-12-10 |
| K212466 | LVivo Seamless | Dia Imaging Analysis, Ltd. | QIH | Class II | 2021-12-09 |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | Infraredx, Inc. | IYO | Class II | 2021-12-07 |
| K213096 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2021-12-06 |
| K210916 | PVmed Contouring Software | Perception Vision Medical Technologies Ltd.Co. | LLZ | Class II | 2021-12-03 |
| K210241 | ImplaStation | Prodigident, Inc. | LLZ | Class II | 2021-12-03 |
| K212442 | Cydar EV (Series B) and Cydar EV Maps | Cydar , Ltd. | OWB | Class II | 2021-12-03 |
| K212295 | 21HQ513D | Lg Electronics.Inc | PGY | Class II | 2021-12-03 |
| K211886 | Clivia series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2021-12-02 |
| K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-12-01 |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | 2021-12-01 |
| K213226 | RCT700 | Ray Co., Ltd. | OAS | Class II | 2021-11-29 |
| K211541 | MammoScreen 2.0 | Therapixel | QDQ | Class II | 2021-11-26 |
| K211983 | AMRA Profiler | Amra Medical AB | LNH | Class II | 2021-11-24 |
| K213455 | ControlRad Select Model Z | Controlrad, Inc. | OWB | Class II | 2021-11-24 |
| K211432 | Myomics Q | Phantomics, Inc. | LLZ | Class II | 2021-11-23 |
| K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2021-11-22 |
| K210831 | OnQ Neuro | Cortechs Labs, Inc. | QIH | Class II | 2021-11-19 |
| K212673 | MR 5300 | Philips Medical Systems Nederland B.V. | LNH | Class II | 2021-11-19 |
| K213070 | MD-320W Ultrasound Biomicroscope | MEDA Co., Ltd. | IYO | Class II | 2021-11-18 |
| K213469 | VALORY | Agfa N.V. | MQB | Class II | 2021-11-18 |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | LNH | Class II | 2021-11-17 |
| K211678 | Lunit INSIGHT MMG | Lunit, Inc. | QDQ | Class II | 2021-11-17 |
| K212336 | Soteria.AI | Omega Medical Imaging, LLC | OWB | Class II | 2021-11-17 |
| K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, 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 | 2021-11-16 |
| K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | IYO | Class II | 2021-11-15 |
| K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | IYN | Class II | 2021-11-15 |
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | MQB | Class II | 2021-11-15 |
| K211876 | Intellijoint VIEW | Intellijoint Surgical, Inc. | LLZ | Class II | 2021-11-12 |
| K212621 | MAMMOVISTA B.smart | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2021-11-12 |
| K212984 | MiPACS HTML5 Web Viewer | Lead Technologies, Inc. | LLZ | Class II | 2021-11-12 |
| K212583 | AlignRT Plus | Vision Rt, Ltd. | IYE | Class II | 2021-11-10 |
| K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | QFM | Class II | 2021-11-10 |
| K210344 | inVisionOS | Precisionos Technology, Inc. | LLZ | Class II | 2021-11-10 |
14,721 clearances in the Radiology panel. Data: openFDA.