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: QIH ×
334 results
97–120 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 26, 2025
Ligence Heart
K252105 · QIH
Ligence Uab
Radiology · 85d
Cleared Sep 25, 2025
Brain WMH
K251527 · QIH
Quantib B.V.
Radiology · 129d
Cleared Sep 23, 2025
SwiftSight-Brain
K251483 · QIH
Airs Medical, Inc.
Radiology · 132d
Cleared Sep 23, 2025
Rapid Aortic Measurements
K251987 · QIH
Ischemaview, Inc.
Radiology · 88d
Cleared Sep 18, 2025
Axial3D Insight
K250369 · QIH
Axial Medical Printing Limited
Radiology · 220d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 10, 2025
AngioWaveNet
K244002 · QIH
Angiowave Imaging, Inc.
Radiology · 258d
Cleared Sep 09, 2025
Segmentron Viewer
K251072 · QIH
DGNCT, LLC
Radiology · 155d
Cleared Sep 04, 2025
Careverse CoronaryDoc (Careverse CoronaryDoc)
K251656 · QIH
Careverse Technology Pte. , Ltd.
Radiology · 97d
Cleared Sep 03, 2025
Tempus Pixel
K252539 · QIH
Arterys, Inc.
Radiology · 22d
Cleared Aug 29, 2025
PRAEVAorta®2
K243859 · QIH
Nurea
Radiology · 256d
Cleared Aug 27, 2025
VistaSoft 4.0 and VisionX 4.0
K250947 · QIH
Durr Dental SE
Radiology · 152d
Cleared Aug 22, 2025
MammoScreen BD
K243685 · QIH
Therapixel
Radiology · 266d
Cleared Aug 22, 2025
GBrain MRI
K252362 · QIH
Galileo Cds, Inc.
Radiology · 24d
Cleared Aug 20, 2025
Salix Coronary Plaque (V1.0.0)
K251837 · QIH
Artrya Limited
Radiology · 65d
Cleared Aug 15, 2025
VEA Align
K251747 · QIH
Eos Imaging
Radiology · 70d
Cleared Aug 12, 2025
DS Core Diagnosis
K250755 · QIH
Dentsply Sirona, Inc.
Radiology · 153d
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Jul 30, 2025
Voxel Dosimetry (00859873006226)
K243919 · QIH
Hermes Medical Solutions AB
Radiology · 222d
Cleared Jul 16, 2025
EchoPAC Software Only / EchoPAC Plug-in
K251342 · QIH
GE Medical Systems Ultrasound and...
Radiology · 77d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 08, 2025
TumorSight Viz
K251766 · QIH
SimBioSys, Inc.
Radiology · 29d
Cleared Jul 03, 2025
syngo.via MI Workflows
K251528 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d