FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
2377–2400 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 24, 2021
I-Q View
K203703 · MQB
First Source, Inc.
Radiology · 96d
Cleared Mar 24, 2021
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
K203225 · JAK
Canon Medical Systems Corporation
Radiology · 142d
Cleared Mar 23, 2021
Viz ICH
K210209 · QAS
Viz. Ai, Inc.
Radiology · 56d