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
193–216 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 23, 2026
True Definition DL
K253686 · JAK
Ge Healthcare Japan Corporation
Radiology · 122d
Cleared Mar 23, 2026
CT Rembra RT
K252992 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 186d
Cleared Mar 20, 2026
Smart Fit TorsoCardiac 1.5T
K260519 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 31d
Cleared Mar 20, 2026
NOMAD Pro 3
K253864 · EHD
Dental Imaging Technologies Corporation
Radiology · 107d
Cleared Mar 20, 2026
SOMATOM X.cite
K253574 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Mar 20, 2026
Photonova Spectra, Photonova Spectra Select
K253520 · JAK
Ge Medical Systems, LLC
Radiology · 128d
Cleared Mar 20, 2026
nordicAudio (1.0)
K251937 · LNH
Nordicneurolab AS
Radiology · 269d
Cleared Mar 19, 2026
AutoContour (RADAC V5)
K260509 · QKB
Radformation, Inc.
Radiology · 30d
Cleared Mar 18, 2026
AlignRT Plus (8.0)
K253012 · IYE
Vision Rt, Ltd.
Radiology · 180d
Cleared Mar 18, 2026
syngo.via RT Image Suite VC10
K252304 · MUJ
Varian Medical Systems, Inc.
Radiology · 237d
Cleared Mar 17, 2026
EchoNavigator R5.0
K253614 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Mar 16, 2026
Data Analysis Facilitation Suite (DAFS)
K253944 · QIH
Voronoi Health Analytics Incorporated
Radiology · 96d
Cleared Mar 16, 2026
Sonio Detect (v3)
K252433 · IYN
Sonio
Radiology · 227d
Cleared Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · LLZ
Boston Scientific Corporation
Radiology · 28d
Cleared Mar 13, 2026
Aquilion ServeSP (TSX-307B) V2.0
K260078 · JAK
Canon Medical Systems Corporation
Radiology · 60d
Cleared Mar 13, 2026
Embrace Neonatal MRI System
K254277 · LNH
Aspect Imaging, Ltd.
Radiology · 73d
Cleared Mar 13, 2026
Aeka Imaging
K253111 · LLZ
Good Methods Global, Inc.
Radiology · 170d
Cleared Mar 13, 2026
InferCare RECIST
K252261 · QIH
Beijing Infervision Healthcare...
Radiology · 235d
Cleared Mar 13, 2026
Extremity CT Imaging System
K252249 · JAK
Mars Bioimaging , Ltd.
Radiology · 238d
Cleared Mar 12, 2026
Dental X-RAY Unit (AJX200)
K252110 · EHD
Guangzhou Ajax Medical Equipment Co.,...
Radiology · 248d
Cleared Mar 12, 2026
Mimics Thoracic Planner
K251964 · LLZ
Materialise NV
Radiology · 259d
Cleared Mar 11, 2026
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
K253185 · IZL
Carestream Health
Radiology · 166d
Cleared Mar 10, 2026
Sonosite iLOOK Ultrasound System
K260595 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 15d
Cleared Mar 10, 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
K253584 · OWB
Canon Medical Systems Corporation
Radiology · 113d