Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 34
- Latest Decision
- 2025-02-20
Clearances · page 9 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K242681 | NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) | Nurodata, Inc. | IYN | Class II | 2025-02-20 |
| K242411 | Brainomix 360 e-Lung | Brainomix Limited | JAK | Class II | 2025-02-19 |
| K243696 | AVIEW CAC | Coreline Soft Co., Ltd. | QIH | Class II | 2025-02-14 |
| K250248 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2025-02-14 |
| K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | POK | Class II | 2025-02-14 |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | OAS | Class II | 2025-02-14 |
| K241425 | AspenView | Aspen Imaging Healthcare, Inc. | LLZ | Class II | 2025-02-12 |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2025-02-12 |
| K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | QIH | Class II | 2025-02-12 |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2025-02-12 |
| K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | LNH | Class II | 2025-02-12 |
| K243620 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-02-11 |
| K243628 | Vivid T9/Vivid T8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-02-11 |
| K241659 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC | QIH | Class II | 2025-02-10 |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | IYE | Class II | 2025-02-07 |
| K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2025-02-06 |
| K241593 | BoneMetrics (US) | Gleamer Sas | QIH | Class II | 2025-02-05 |
| K243333 | rTOP | Roclub GmbH | LLZ | Class II | 2025-02-04 |
| K250035 | Contour ProtégéAI+ | Mim Software, Inc. | QKB | Class II | 2025-02-03 |
| K241694 | ZeTTA PACS | Tae Young Soft Co., Ltd. | LLZ | Class II | 2025-01-31 |
| K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | KPS | Class II | 2025-01-27 |
| K243229 | Bunkerhill AVC | BunkerHill Health | JAK | Class II | 2025-01-27 |
| K241819 | CephNinja | Cyncronus, LLC | LLZ | Class II | 2025-01-23 |
| K243158 | TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. | QIH | Class II | 2025-01-23 |
| K243350 | Rapid Neuro3D | Ischemaview, Inc. | QIH | Class II | 2025-01-22 |
| K243303 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | OWB | Class II | 2025-01-21 |
| K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | KPS | Class II | 2025-01-17 |
| K242171 | TechCare Trauma | Milvue | QBS | Class II | 2025-01-17 |
| K242825 | Prenuvo Body Composition | Prenuvo | LNH | Class II | 2025-01-17 |
| K243218 | TBS iNsight (V4) | Medimaps Group SA | KGI | Class II | 2025-01-17 |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. | IYN | Class II | 2025-01-17 |
| K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | Olympus Medical Systems Corporation | IYN | Class II | 2025-01-17 |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | MUE | Class II | 2025-01-16 |
| K242522 | Second Opinion CC | Pearl, Inc. | MYN | Class II | 2025-01-16 |
| K243328 | Ziehm Vision RFD | Ziehm Imaging GmbH | OWB | Class II | 2025-01-15 |
| K243065 | Cardiac Guidance | Caption Health, Inc. | QJU | Class II | 2025-01-15 |
| K242205 | SpectoMed (v1.0) | Specto Medical | LLZ | Class II | 2025-01-14 |
| K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2025-01-14 |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | OXO | Class II | 2025-01-14 |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. | JAK | Class II | 2025-01-13 |
| K241891 | ScreenDx | Imvaria, Inc. | QWO | Class II | 2025-01-10 |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | JAQ | Class II | 2025-01-10 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Carl Zeiss Meditec, AG | JAD | Class II | 2025-01-10 |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | OAS | Class II | 2025-01-09 |
| K241808 | ApolloHipX (THR.SS.0001) | Corin U.S.A. Limited | LLZ | Class II | 2025-01-07 |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2025-01-07 |
| K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2025-01-07 |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | KPR | Class II | 2025-01-07 |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | JAA | Class II | 2025-01-06 |
| K242123 | Brainomix 360 e-CTA | Brainomix Limited | LLZ | Class II | 2025-01-06 |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | KPR | Class II | 2025-01-06 |
| K241350 | Clarify DL | Ge Medical Systems Israel, Functional Imaging | LLZ | Class II | 2025-01-03 |
| K241757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2025-01-03 |
| K242119 | INNOVISION-EXII | Dk Medical System | KPR | Class II | 2025-01-03 |
| K243363 | JLK-ICH | JLK, Inc. | QAS | Class II | 2025-01-03 |
| K242334 | Ezra Flash | Ezra Ai, Inc. | QIH | Class II | 2025-01-02 |
| K241696 | Ortho AI | Ortho Ai, LLC | QIH | Class II | 2025-01-02 |
| K243084 | BioTraceIO Precision (2.0) | Techsomed Medical Technologies , Ltd. | QZL | Class II | 2024-12-27 |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | OXO | Class II | 2024-12-27 |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | JAA | Class II | 2024-12-23 |
| K242573 | NIDO Baby Magnetic Resonance Imaging System | Jiangsu Lici Medical Device Co., Ltd. | LNH | Class II | 2024-12-23 |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | JAK | Class II | 2024-12-23 |
| K242599 | aprevo® Digital Planning | Carlsmed, Inc. | LLZ | Class II | 2024-12-20 |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | MOS | Class II | 2024-12-20 |
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2024-12-20 |
| K242362 | Lightning Viewer | Nexsys Electronics Inc. Dba Medweb | LLZ | Class II | 2024-12-20 |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | MQB | Class II | 2024-12-19 |
| K243705 | Saige-Density (2.5.0) | DeepHealth, Inc. | QIH | Class II | 2024-12-19 |
| K242270 | OrthoNext Platform System | Orthofix Srl | QIH | Class II | 2024-12-19 |
| K243688 | Saige-Dx (3.1.0) | DeepHealth, Inc. | QDQ | Class II | 2024-12-19 |
| K242467 | IQ-UIP | Imbio, Inc. | QWO | Class II | 2024-12-19 |
| K240676 | ULTIMUS Series Ultrasound Diagnostic System | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | 2024-12-16 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | IZL | Class II | 2024-12-16 |
| K240793 | MSKai | Mskai | QIH | Class II | 2024-12-16 |
| K242124 | Sim&Size | Sim&Cure | PZO | Class II | 2024-12-14 |
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | JAF | Class II | 2024-12-13 |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | MUJ | Class II | 2024-12-13 |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2024-12-12 |
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2024-12-12 |
| K243548 | BriefCase-Triage | Aidoc Medical , Ltd. | QFM | Class II | 2024-12-11 |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | MUJ | Class II | 2024-12-11 |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | IZL | Class II | 2024-12-10 |
| K242461 | IRISeg | Intuitive Surgical, Inc. | QIH | Class II | 2024-12-10 |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2024-12-10 |
| K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | IYN | Class II | 2024-12-10 |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | QKB | Class II | 2024-12-09 |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | IZL | Class II | 2024-12-09 |
| K240926 | PeekMed web | Peek Health, S.A. | LLZ | Class II | 2024-12-06 |
| K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical A/S | LLZ | Class II | 2024-12-06 |
| K242524 | SyMRI | Syntheticmr AB (Publ.) | LNH | Class II | 2024-12-06 |
| K241567 | MC2 Portable X-ray System | Oxos Medical | OWB | Class II | 2024-12-06 |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | 2024-12-06 |
| K240680 | CDM Insights | Oxford Brain Diagnostics, Ltd. | QIH | Class II | 2024-12-06 |
| K241543 | DrAid for Liver Segmentation | Vinbrain Joint Stock Company | QIH | Class II | 2024-12-06 |
| K243447 | Rapid Surgical Plan (RSP-SW-001) | Navbit Pty, Ltd. | LLZ | Class II | 2024-12-05 |
| K240671 | XBeam (v2) | Xstrahl, Ltd. | MUJ | Class II | 2024-12-04 |
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | IZF | Class II | 2024-12-04 |
| K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | JAK | Class II | 2024-12-03 |
| K240645 | Sonix Health | Ontact Health Co., Ltd. | QIH | Class II | 2024-11-27 |
| K243221 | RadiForce RX570; RadiForce RX570-AR | Eizo Corporation | PGY | Class II | 2024-11-27 |
14,721 clearances in the Radiology panel. Data: openFDA.