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
577–600 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 21, 2025
Swoop® Portable MR Imaging® System
K251276 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared May 21, 2025
SMARTDent
K251109 · LLZ
Ray Co., Ltd.
Radiology · 40d
Cleared May 21, 2025
EPIQ Series Diagnostic Ultrasound System
K243793 · IYN
Philips Ultrasound, LLC
Radiology · 162d
Cleared May 21, 2025
Synapse 3D Base Tools (V7.0)
K243762 · QIH
Fujifilm Corporation
Radiology · 166d
Cleared May 21, 2025
uMR Omega
K243122 · LNH
Shanghai United Imaging Healthcare...
Radiology · 233d
Cleared May 20, 2025
SCENARIA View Phase 5.0
K250370 · JAK
Fujifilm Corporation
Radiology · 99d
Cleared May 19, 2025
Diagnostic Ultrasound System (Recho R9W)
K250020 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 136d
Cleared May 19, 2025
Diagnostic X-ray System
K243411 · OWB
Nanjing Perlove Medical Equipment...
Radiology · 199d
Cleared May 19, 2025
MapRT
K243301 · IYE
Vision Rt, Ltd.
Radiology · 213d
Cleared May 16, 2025
Diagnostic Ultrasound System (MX6)
K250110 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 120d
Cleared May 16, 2025
Mobius3D (4.1)
K250099 · IYE
Varian Medical Systems
Radiology · 122d
Cleared May 16, 2025
Spectral CT
K244008 · JAK
Philips Medical Systems Technologies...
Radiology · 141d
Cleared May 16, 2025
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · JAK
Shanghai United Imaging Healthcare...
Radiology · 175d
Cleared May 16, 2025
MasteRad MiniX Mobile Digital Imaging System (Mini-X)
K242731 · OWB
Medicatech USA, Inc.
Radiology · 248d
Cleared May 16, 2025
6450 Ultrasound System (MyLabE80)
K241671 · IYN
Esaote, S.P.A.
Radiology · 339d
Cleared May 16, 2025
InferRead Lung CT.AI
K240554 · OEB
Infervision Medical Technology Co., Ltd.
Radiology · 443d
Cleared May 15, 2025
Lumify Diagnostic Ultrasound System
K242519 · IYN
Philips Ultrasound
Radiology · 265d
Cleared May 14, 2025
Medical Image Post-processing Software (uOmnispace.CT)
K242624 · QIH
Shanghai United Imaging Healthcare...
Radiology · 253d
Cleared May 14, 2025
Smile Dx®
K242437 · MYN
Cube Click, Inc.
Radiology · 271d
Cleared May 13, 2025
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
K242808 · IYN
Canon Medical Systems Corporation
Radiology · 238d
Cleared May 12, 2025
uWS-Angio Basic
K243632 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 168d
Cleared May 12, 2025
P-Cure Proton Therapy System (PPTS)
K242418 · LHN
P-Cure, Ltd.
Radiology · 270d
Cleared May 09, 2025
EPIQ Series Diagnostic Ultrasound Systems
K251110 · IYN
Philips Ultrasound, LLC
Radiology · 28d
Cleared May 09, 2025
CT/ MR Tandem and Ovoid Set
K250299 · JAQ
Varian Medical Systems, Inc.
Radiology · 98d