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
2449–2472 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 12, 2021
TaiChiC
K203250 · IWB
Our United Corporation
Radiology · 128d