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 × Cleared only ×
15,676 results
97–120 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 10, 2026
EM-TECH Passive Ultrasound Probe Strap
K254143 · ITX
EM-TECH Solutions, Inc.
Radiology · 231d
Cleared Aug 10, 2026
Prostate Core
K253794 · QIH
Lucida Medical, Ltd.
Radiology · 255d
Cleared Aug 07, 2026
Venue Go
K261668 · IYN
GE Medical Systems Ultrasound and...
Radiology · 79d
Cleared Aug 07, 2026
Zenition 30
K254205 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 221d
Cleared Aug 07, 2026
mdprostate
K252571 · QIH
Mediaire GmbH
Radiology · 358d
Cleared Aug 06, 2026
Overjet Multi-Image Caries and Charting Assist
K261059 · MYN
Overjet, Inc.
Radiology · 128d
Cleared Aug 04, 2026
Alturion Series Diagnostic Ultrasound System
K262311 · IYN
Philips Ultrasound, LLC
Radiology · 27d
Cleared Aug 04, 2026
RealGUIDE
K253902 · QIH
3DIEMME SRL
Radiology · 242d
Cleared Aug 03, 2026
Halcyon, Ethos Radiotherapy System (5.0)
K261856 · IYE
Varian Medical Systems, Inc.
Radiology · 60d
Cleared Aug 03, 2026
XLITE
K260236 · IZL
GEMSS HEALTHCARE CO., LTD.
Radiology · 189d
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