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 × Cleared only ×
15,570 results
97–120 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 27, 2026
Portable Dental X-ray System Model PDX nova
K260367 · EHD
PDX Co., Ltd.
Radiology · 112d
Cleared May 27, 2026
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
K260207 · MUJ
Philips Medical Systems Nederland B.V.
Radiology · 124d
Cleared May 27, 2026
EPIQ Series Diagnostic Ultrasound System
K260123 · IYN
Philips Ultrasound, LLC
Radiology · 132d
Cleared May 27, 2026
Helion Viewer Suite
K254265 · LLZ
Videomed Srl ( a Baxter Healthcare...
Radiology · 148d
Cleared May 27, 2026
Synapse Lung Nodule AI
K254075 · OEB
Fujifilm Corporation
Radiology · 160d
Cleared May 26, 2026
LOGIQ e
K260398 · IYN
GE Medical Systems Ultrasound and...
Radiology · 109d
Cleared May 22, 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K260324 · QIH
Canon Medical Informatics, Inc.
Radiology · 112d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared May 22, 2026
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort...
K253949 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 163d
Cleared May 22, 2026
eXaSkin Plus
K252784 · MUJ
Anatomical Geometry S.L.
Radiology · 262d
Cleared May 22, 2026
C-beam
K252735 · OWB
Pulmera, Inc.
Radiology · 267d
Cleared May 21, 2026
Symbia Pro.specta Q3 (11364751)
K261315 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 21, 2026
MSK Go
K260234 · QIH
Smart Alfa Teknoloji San. Ve Tic. A.S.
Radiology · 115d
Cleared May 21, 2026
BAC
K254131 · QIH
DeepHealth, Inc.
Radiology · 150d
Cleared May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite,...
K253720 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 178d
Cleared May 20, 2026
Derma-2
K253911 · LHQ
Neko Health AB
Radiology · 163d
Cleared May 20, 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
K253596 · JAK
Canon Medical Systems Corporation
Radiology · 183d
Cleared May 20, 2026
MAASTRO Rectal Applicator Set
K252717 · JAQ
Varian Medical Systems
Radiology · 265d
Cleared May 18, 2026
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
K253831 · LLZ
Cercare Medical A/S
Radiology · 168d
Cleared May 15, 2026
UNiD™ Spine Analyzer (SW3002)
K261289 · QIH
Medicrea International S.A.S....
Radiology · 25d
Cleared May 15, 2026
Neurophet AQUA
K261273 · QIH
Neurophet., Inc.
Radiology · 28d
Cleared May 15, 2026
SubtleHD-CT (1.x)
K254120 · QIH
Subtle Medical, Inc.
Radiology · 147d
Cleared May 15, 2026
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior,...
K254028 · IYN
Sonoscape Medical Corp.
Radiology · 150d
Cleared May 15, 2026
medXion NEXUS
K253935 · OAS
medXion Technologies, Inc.
Radiology · 157d