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
2353–2376 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 23, 2021
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
K203391 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 125d
Cleared Mar 19, 2021
IMPACT and X-Ranger
K210479 · IZL
Minxray, Inc.
Radiology · 28d
Cleared Mar 19, 2021
VBrain
K203235 · QKB
Vysioneer, Inc.
Radiology · 136d
Cleared Mar 19, 2021
SensorX
K203116 · MUH
Durr Dental SE
Radiology · 154d
Cleared Mar 17, 2021
BBX-PET Scanner
K210450 · KPS
Prescient Imaging, LLC
Radiology · 29d
Cleared Mar 17, 2021
Ziehm Vision RFD
K203428 · JAA
Ziehm Imaging GmbH
Radiology · 117d
Cleared Mar 12, 2021
ProFound AI Software V3.0
K203822 · QDQ
Icad, Inc.
Radiology · 73d