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
1–24 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 31, 2026
I-Genius (100019400)
K261331 · LNH
Esaote, S.P.A.
Radiology · 100d
Cleared Jul 31, 2026
RadioViewAI
K260936 · LLZ
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 133d
Cleared Jul 31, 2026
MAGNETOM Flow.Elite
K260852 · LNH
Siemens Healthineers AG
Radiology · 137d
Cleared Jul 31, 2026
Shield System (Siemens 30x40)
K260607 · OWB
Radiaction , Ltd.
Radiology · 157d
Cleared Jul 31, 2026
Affinity
K253835 · QIH
Hermes Medical Solutions AB
Radiology · 242d
Cleared Jul 31, 2026
0909FCE, 0909FCE-HS
K253800 · MQB
Rayence Co., Ltd.
Radiology · 245d
Cleared Jul 30, 2026
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS...
K262330 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 21d
Cleared Jul 30, 2026
LOGIQ Focus
K261835 · IYN
GE Medical Systems Ultrasound and...
Radiology · 58d
Cleared Jul 30, 2026
Handheld Ultrasound Scanner
K261288 · IYN
IMGFAX CO., LTD.
Radiology · 101d
Cleared Jul 30, 2026
cmAngio® V2.0
K260980 · QIH
Curemetrix, Inc.
Radiology · 127d
Cleared Jul 30, 2026
SmartGuide Disposable Guides and Grids
K260161 · ITX
UC-CARE , Ltd.
Radiology · 191d
Cleared Jul 29, 2026
Cleerly Plaque
K261210 · QIH
Cleerly, Inc.
Radiology · 106d
Cleared Jul 29, 2026
Cleerly LABS
K260588 · LLZ
Cleerly, Inc.
Radiology · 159d
Cleared Jul 28, 2026
uMI Panvivo (uMI Panvivo M)
K261427 · KPS
Shanghai United Imaging Healthcare...
Radiology · 89d
Cleared Jul 28, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound...
K261412 · IYN
Samsung Medison Co., Ltd.
Radiology · 89d
Cleared Jul 28, 2026
See-Mode Augmented Reporting Tool, Breast (SMART-B)
K260303 · QDQ
See-Mode Technologies Pty, Ltd.
Radiology · 179d
Cleared Jul 28, 2026
BodyTom Elite (NL4000)
K253450 · JAK
NeuroLogica Corp., a Samsung Company
Radiology · 299d
Cleared Jul 27, 2026
ND Needle Guidance System
K262474 · ITX
Accurate Access, LLC
Radiology · 10d
Cleared Jul 27, 2026
Philips EPIQ Series Diagnostic Ultrasound System
K261211 · IYN
Philips Ultrasound, LLC
Radiology · 104d
Cleared Jul 24, 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · LLZ
Boston Scientific Corporation
Radiology · 7d
Cleared Jul 24, 2026
LumenCare Azure
K262383 · JAQ
Nucletron B.V.
Radiology · 11d
Cleared Jul 24, 2026
dS FootAnkle 16Ch 1.5T
K262294 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 17d
Cleared Jul 24, 2026
SwiftMR
K261349 · QIH
Airs Medical, Inc.
Radiology · 91d
Cleared Jul 24, 2026
Accuro® 3S Needle Guide Kit
K261014 · ITX
Rivanna Medical, Inc.
Radiology · 119d