Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology ×
15,695 results
1705–1728 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 01, 2023
LVivo IQS
K222970 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 127d
Cleared Feb 01, 2023
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
K213480 · MOS
Rapid Biomedical GmbH
Radiology · 460d
Not Cleared Feb 01, 2023
RefleXion Medical Radiotherapy System (RMRS)
DEN220014 · QVA
Reflexion Medical, Inc.
Radiology · 343d
Cleared Jan 27, 2023
14HQ721G-B
K223546 · MQB
Lg Electronics.Inc
Radiology · 63d
Cleared Jan 27, 2023
QOCA image Smart CXR Image Processing System
K221868 · QFM
Quanta Computer, Inc.
Radiology · 214d
Cleared Jan 26, 2023
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
K221949 · IZF
Pausch Medical GmbH
Radiology · 205d
Cleared Jan 26, 2023
ECHELON Oval V6.2 MRI System
K221619 · LNH
Fujifilm Healthcare Corporation
Radiology · 237d
Cleared Jan 26, 2023
RMF-2000
K220073 · MUE
DRTECH Corporation
Radiology · 381d
Cleared Jan 23, 2023
Clarius AI
K222406 · QIH
Clarius Mobile Health Corp.
Radiology · 167d
Cleared Jan 20, 2023
DRX - Compass
K223842 · KPR
Carestream Health, Inc.
Radiology · 29d
Cleared Jan 20, 2023
Advanced MyHip Planner
K221725 · LLZ
Medacta International S.A.
Radiology · 220d
Cleared Jan 19, 2023
PerfusionGo Plus
K221627 · LLZ
Yukun (Beijing) Technology Co., Ltd.
Radiology · 227d
Cleared Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
K223804 · JAK
Philips Ultrasound, LLC
Radiology · 30d
Cleared Jan 18, 2023
TruPlan Computed Tomography (CT) Imaging Software
K222593 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 145d
Cleared Jan 17, 2023
MIM – Additional Tracers
K223800 · LLZ
Mim Software, Inc.
Radiology · 29d
Cleared Jan 17, 2023
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K223794 · OAS
Cefla S.C.
Radiology · 29d
Cleared Jan 17, 2023
Portable X-ray System
K223010 · EHD
Iray Technology Taicang , Ltd.
Radiology · 110d
Cleared Jan 17, 2023
Halcyon, Ethos Radiotherapy System
K222941 · IYE
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Jan 17, 2023
Elucis
K220649 · LLZ
Realize Medical, Inc.
Radiology · 316d
Cleared Jan 13, 2023
MR Diffusion Perfusion Mismatch V1.0
K223502 · LLZ
Olea Medical
Radiology · 53d
Cleared Jan 13, 2023
Contour Knee
K223429 · MOS
Quality Electrodynamics, LLC
Radiology · 60d
Cleared Jan 12, 2023
MAMMOVISTA B.smart (VB70)
K223363 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 12, 2023
AIBOLIT 3D+
K222458 · LLZ
Aibolit Technologies, LLC
Radiology · 150d
Cleared Jan 12, 2023
PreXion3D Expedition
K222150 · OAS
Prexion Corporation
Radiology · 176d