Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 35
- Latest Decision
- 2025-12-17
Clearances · page 5 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251416 | UltraSight Guidance | Ultrasight , Ltd. | QJU | Class II | 2025-12-17 |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | OWB | Class II | 2025-12-16 |
| K251763 | IRISeg | Intuitive Surgical, Inc. | QIH | Class II | 2025-12-16 |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | IYE | Class II | 2025-12-16 |
| K253101 | HyperVue Imaging System - Integrated | Spectrawave, Inc. | NQQ | Class II | 2025-12-15 |
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | LNH | Class II | 2025-12-12 |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc. | QFM | Class II | 2025-12-11 |
| K251883 | MIM LesionID Pro | Mim Software, Inc. | LLZ | Class II | 2025-12-11 |
| K251199 | Allia Moveo | GE Medical Systems SCS | OWB | Class II | 2025-12-09 |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | POK | Class II | 2025-12-08 |
| K252296 | OncoPatch | Oncopatch, Inc. | KXK | Class II | 2025-12-05 |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) | Sonoscape Medical Corp. | IYN | Class II | 2025-12-05 |
| K251514 | Overjet CBCT Assist | Overjet, Inc. | QIH | Class II | 2025-12-05 |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | QKB | Class II | 2025-12-05 |
| K250791 | ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. | IYN | Class II | 2025-12-04 |
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | JAD | Class II | 2025-12-03 |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | OEB | Class II | 2025-12-03 |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-12-03 |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | QIH | Class II | 2025-12-02 |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | KPS | Class II | 2025-12-01 |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | JAK | Class II | 2025-11-28 |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | OXO | Class II | 2025-11-26 |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | 2025-11-26 |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.p.A. | IYN | Class II | 2025-11-25 |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | QAS | Class II | 2025-11-25 |
| K251798 | RCT700 | Ray Co., Ltd. | OAS | Class II | 2025-11-25 |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | KPS | Class II | 2025-11-25 |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-11-24 |
| K252366 | a2z-Unified-Triage | A2z Radiology Ai, Inc. | QAS | Class II | 2025-11-24 |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | LLZ | Class II | 2025-11-21 |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | LLZ | Class II | 2025-11-20 |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | MUJ | Class II | 2025-11-20 |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | Class II | 2025-11-20 |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | JAQ | Class II | 2025-11-19 |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2025-11-17 |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | MYN | Class II | 2025-11-17 |
| K251078 | AutoDensity | Eos Imaging | QIH | Class II | 2025-11-14 |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | MYN | Class II | 2025-11-14 |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | OAS | Class II | 2025-11-13 |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2025-11-13 |
| K252452 | PeekMed web | Peek Health, S.A. | QIH | Class II | 2025-11-12 |
| K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | QWO | Class II | 2025-11-07 |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2025-11-07 |
| K250264 | SugarBug (1.x) | Bench7, Inc. | MYN | Class II | 2025-11-07 |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | OXO | Class II | 2025-11-06 |
| K253265 | BriefCase-Triage | Aidoc Medical , Ltd. | QAS | Class II | 2025-11-06 |
| K252133 | Adaptix Ortho350 | Adaptix Limited | IZF | Class II | 2025-11-06 |
| K251410 | VXvue | Vieworks Co., Ltd. | LLZ | Class II | 2025-11-04 |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2025-11-04 |
| K250330 | 3mensio Workstation | Pie Medical Imaging BV | QIH | Class II | 2025-11-03 |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | IYE | Class II | 2025-11-03 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | LLZ | Class II | 2025-11-03 |
| K253448 | Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2025-11-03 |
| DEN240074 | Pulsenmore ES | Pulsenmore, Ltd. | SGJ | Class II | 2025-10-31 |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2025-10-31 |
| K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | QIH | Class II | 2025-10-30 |
| K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2025-10-29 |
| K251985 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-10-29 |
| K251963 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2025-10-29 |
| K252547 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | LLZ | Class II | 2025-10-28 |
| K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | QIH | Class II | 2025-10-27 |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | IYE | Class II | 2025-10-24 |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | IZL | Class II | 2025-10-24 |
| K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | QIH | Class II | 2025-10-24 |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. | OWB | Class II | 2025-10-24 |
| K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | QIH | Class II | 2025-10-23 |
| K252298 | ANDI 2.0 | Imeka Solutions, Inc. | QIH | Class II | 2025-10-22 |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | LLZ | Class II | 2025-10-22 |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | MOS | Class II | 2025-10-20 |
| K252665 | brAIn Shoulder Positioning | Avatar Medical | QIH | Class II | 2025-10-20 |
| K251355 | X1-FFR | Spectrawave, Inc. | QHA | Class II | 2025-10-17 |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | IYE | Class II | 2025-10-17 |
| K251673 | X9 Ultrasound System | X9, Inc. | SGH | Class II | 2025-10-17 |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | LLZ | Class II | 2025-10-16 |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | LLZ | Class II | 2025-10-15 |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2025-10-15 |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | OWB | Class II | 2025-10-10 |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2025-10-09 |
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | MQB | Class II | 2025-10-09 |
| K251363 | ProKnow DS | Elekta Solutions AB | LLZ | Class II | 2025-10-08 |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | OAS | Class II | 2025-10-08 |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | NQQ | Class II | 2025-10-07 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | 2025-10-07 |
| K252214 | AIAS Cephalon | Metamorphosis GmbH | QIH | Class II | 2025-10-07 |
| K252007 | BlineSlide | Deep Breathe, Inc. | QIH | Class II | 2025-10-06 |
| K250039 | HPACS | Healthhub | LLZ | Class II | 2025-10-03 |
| K250662 | Bunkerhill MAC | BunkerHill Health | JAK | Class II | 2025-10-03 |
| K250766 | LungQ 4 | Thirona BV | JAK | Class II | 2025-10-02 |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2025-10-02 |
| K250083 | PRO-DOSE System | Nu-Rise, SA | NZT | Class II | 2025-10-01 |
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | Wuxi Hisky Medical Technologies Co., Ltd. | IYN | Class II | 2025-10-01 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | IYO | Class II | 2025-09-30 |
| K250023 | SMART PCFD | Disior, Ltd. | QIH | Class II | 2025-09-29 |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation | JAK | Class II | 2025-09-26 |
| K252105 | Ligence Heart | Ligence Uab | QIH | Class II | 2025-09-26 |
| K250318 | Planmed XFI | Planmed OY | SFV | Class II | 2025-09-26 |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2025-09-25 |
| K251527 | Brain WMH | Quantib B.V. | QIH | Class II | 2025-09-25 |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2025-09-24 |
| K251483 | SwiftSight-Brain | Airs Medical, Inc. | QIH | Class II | 2025-09-23 |
14,721 clearances in the Radiology panel. Data: openFDA.