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 × Cleared only ×
15,676 results
1705–1728 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jan 11, 2023
RadianceTx Radionuclide Brachytherapy Source
K223465 · KXK
Radiance Therapeutics, Inc.
Radiology · 55d
Cleared Jan 11, 2023
Transducer Probe Cover
K221278 · ITX
Hony Medical Co., Ltd.
Radiology · 253d
Cleared Jan 09, 2023
21HQ513D
K223789 · PGY
Lg Electronics.Inc
Radiology · 21d
Cleared Jan 09, 2023
Vitrea Software Package, VSTP-002A
K223336 · LLZ
Canon Medical Systems Corporation
Radiology · 69d
Cleared Jan 09, 2023
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B,...
K222787 · IYO
Chongqing Sunkingdom Medical...
Radiology · 116d
Cleared Jan 06, 2023
TECHFIT Diagnostic Models
K222577 · LLZ
Techfit Digital Surgery, Inc.
Radiology · 134d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d
Cleared Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
K223687 · MQB
Careray Digital Medical Technology...
Radiology · 21d
Cleared Dec 30, 2022
PeekMed web (v1)
K222767 · LLZ
Peek Health, S.A.
Radiology · 108d