Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology ×
15,695 results
697–720 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
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