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
601–624 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Apr 23, 2025
Annalise Enterprise
K250831 · QFM
Annalise-Ai
Radiology · 35d
Cleared Apr 23, 2025
eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E,...
K250228 · IYN
Esonic Technology (Wuhan) Co., Ltd.
Radiology · 86d
Cleared Apr 23, 2025
MySpine WebPlanner
K243697 · LLZ
Medacta International S.A.
Radiology · 145d
Cleared Apr 21, 2025
VersaViewer
K243651 · LLZ
GE Medical Systems SCS
Radiology · 146d
Cleared Apr 18, 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · MQB
Allengers Medical Systems Limited
Radiology · 135d
Cleared Apr 18, 2025
ULTRA 1040
K241996 · IZL
Ecoray Co., Ltd.
Radiology · 283d
Cleared Apr 17, 2025
Dental Cone Beam Computed Tomography System
K243337 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 174d