FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
1609–1632 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Dec 30, 2022
aprevo® Digital Workflow
K222195 · LLZ
Carlsmed, Inc.
Radiology · 161d