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
433–456 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 03, 2025
GentleBeam (GB1000)
K250692 · JAD
Voxel Ray Solutions, LLC
Radiology · 271d
Cleared Dec 02, 2025
Acorn 3D Software (AC-SEG-4009)
K252103 · QIH
Mighty Oak Medical
Radiology · 152d
Cleared Dec 01, 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · KPS
Canon Medical Systems Corporation
Radiology · 213d
Cleared Nov 28, 2025
CT VScore+
K252217 · JAK
Canon Medical Informatics, Inc.
Radiology · 136d
Cleared Nov 26, 2025
OEC One CFD
K253269 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 58d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Nov 25, 2025
7600 Ultrasound System (MyLabC25)
K253310 · IYN
Esaote, S.P.A.
Radiology · 57d
Cleared Nov 25, 2025
RCT700
K251798 · OAS
Ray Co., Ltd.
Radiology · 166d
Cleared Nov 25, 2025
PennPET Explorer Positron Emission Tomograph
K251401 · KPS
Trustees of the University of...
Radiology · 203d
Cleared Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
K250694 · QAS
Mlhealth 360
Radiology · 263d
Cleared Nov 24, 2025
a2z-Unified-Triage
K252366 · QAS
A2z Radiology Ai, Inc.
Radiology · 117d
Cleared Nov 24, 2025
Voluson Expert 18
K252328 · IYN
GE Medical Systems Ultrasound and...
Radiology · 122d
Cleared Nov 21, 2025
Archy Dental Imaging
K251880 · LLZ
Archy Dental, Inc.
Radiology · 156d
Cleared Nov 20, 2025
syngo.MR Applications (VB80)
K253495 · LLZ
Siemens Healthineers AG
Radiology · 23d
Cleared Nov 20, 2025
MAGNETOM Free.Max
K251822 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 160d
Cleared Nov 20, 2025
PlanOne 1
K250963 · MUJ
Cosylab Jsc, Control System Laboratory
Radiology · 234d
Cleared Nov 19, 2025
Guided Aarhus Applicator Set
K252884 · JAQ
Varian Medical Systems
Radiology · 70d
Cleared Nov 17, 2025
ACUSON Maple Diagnostic Ultrasound System
K253487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Nov 17, 2025
DTX Studio Assist
K252086 · MYN
Nobel Biocare C/O Medicim NV
Radiology · 138d
Cleared Nov 14, 2025
AutoDensity
K251078 · QIH
Eos Imaging
Radiology · 220d
Cleared Nov 14, 2025
Second Opinion® Panoramic
K250525 · MYN
Pearl, Inc.
Radiology · 266d
Cleared Nov 13, 2025
ACUSON Juniper Diagnostic Ultrasound System
K253457 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 13, 2025
Dental Computed Tomography X-ray System
K251842 · OAS
Fussen Technology Co., Ltd.
Radiology · 150d
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d