FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
625–648 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 09, 2025
Second Opinion® BLE
K243230 · QIH
Pearl, Inc.
Radiology · 213d
Cleared May 08, 2025
Clarius Median Nerve AI
K250226 · QIH
Clarius Mobile Health Corp.
Radiology · 101d
Cleared May 08, 2025
Ultrasound Imaging System (LU700 Series)
K243226 · IYN
Leltek, Inc.
Radiology · 212d
Cleared May 08, 2025
Lumify Diagnostic Ultrasound System
K242670 · IYN
Philips Ultrasound
Radiology · 245d
Cleared May 07, 2025
BrightHeart View Classifier
K243684 · QIH
Brightheart
Radiology · 159d
Cleared May 06, 2025
!M1
K241980 · IZL
Solutions For Tomorrow AB
Radiology · 305d
Cleared May 05, 2025
Second Opinion® Pediatric
K243893 · MYN
Pearl, Inc.
Radiology · 138d
Cleared May 02, 2025
Fetal EchoScan (v1.1)
K251071 · POK
Brightheart
Radiology · 25d
Cleared May 02, 2025
LUMYS (V1)
K243069 · LLZ
Intradys
Radiology · 217d
Cleared May 01, 2025
Vscan Air
K250087 · IYN
GE Medical Systems Ultrasound and...
Radiology · 107d
Cleared Apr 30, 2025
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
K250328 · QIH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Apr 30, 2025
Persona C HR
K250282 · OWB
A.T.S. Applicazione Tecnologie...
Radiology · 89d
Cleared Apr 28, 2025
Flash Ultrasound System 5100 Point of Care
K250030 · IYN
Philips Ultrasound, LLC
Radiology · 112d
Cleared Apr 28, 2025
uAngio AVIVA CX
K243376 · OWB
Shanghai United Imaging Healthcare...
Radiology · 180d
Cleared Apr 25, 2025
Intracavitary/Interstitial System
K250289 · JAQ
Varian Medical Systems
Radiology · 84d
Cleared Apr 25, 2025
Kosmos
K242321 · IYN
EchoNous, Inc.
Radiology · 262d
Cleared Apr 24, 2025
Lung AI (LAI001)
K243239 · MYN
Exo, Inc.
Radiology · 196d