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
2449–2472 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 14, 2021
BriefCase, RIB Fractures Triage (RibFx)
K202992 · QFM
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K210900 · OWB
Canon Medical Systems Corporation
Radiology · 17d
Cleared Apr 12, 2021
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -...
K202679 · KPS
Mcgovern Medical School
Radiology · 209d
Cleared Apr 09, 2021
HYPER Focus
K210418 · KPS
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Apr 09, 2021
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
K210068 · IYN
Samsung Medison Co., Ltd.
Radiology · 88d
Cleared Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS,...
K203681 · MUJ
Brainlab AG
Radiology · 113d
Cleared Apr 09, 2021
DeepLook PRECISE
K202084 · LLZ
Deeplook, Inc.
Radiology · 256d
Cleared Apr 08, 2021
CW120N
K210491 · PGY
Wide Corporation
Radiology · 48d
Cleared Apr 08, 2021
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa...
K202785 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 198d
Cleared Apr 05, 2021
ADAS 3D
K210850 · LLZ
Adas3D Medical S.L.
Radiology · 14d
Cleared Apr 05, 2021
StentBoost Mobile
K203623 · OWB
Philips India Limited
Radiology · 115d
Cleared Apr 02, 2021
DigitalDiagnost
K210692 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 25d
Cleared Apr 02, 2021
DV. Target
K202928 · QKB
Deepvoxel, Inc.
Radiology · 185d
Cleared Apr 02, 2021
Eclipse II with Smart Noise Cancellation
K202441 · MQB
Carestream Health, Inc.
Radiology · 219d
Cleared Apr 01, 2021
ACUSON Redwood Diagnostic Ultrasound System
K210743 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K210340 · LNH
Canon Medical Systems Corporation
Radiology · 55d
Cleared Apr 01, 2021
Nanox Cart X-ray System
K203782 · IZL
Nano-X Imaging , Ltd.
Radiology · 94d
Cleared Apr 01, 2021
Simpleware ScanIP Medical
K203195 · LLZ
Synopsys (Northern Europe) , Ltd.
Radiology · 155d
Cleared Mar 31, 2021
SIS System (Version 5.1.0)
K210071 · LLZ
Surgical Information Sciences, Inc.
Radiology · 79d
Cleared Mar 31, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
K203443 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 31, 2021
syngo.CT Lung CAD
K203258 · OEB
Siemens Healthcare GmbH
Radiology · 146d
Cleared Mar 29, 2021
StarGuide
K210173 · KPS
Ge Healthcare
Radiology · 66d
Cleared Mar 26, 2021
Surgivisio system
K202547 · OWB
Surgivisio
Radiology · 205d
Cleared Mar 25, 2021
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and...
K203273 · IYO
Echosens
Radiology · 139d