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: QIH ×
313 results
73–96 of 313
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 07, 2025
AIAS Cephalon
K252214 · QIH
Metamorphosis GmbH
Radiology · 84d
Cleared Oct 06, 2025
BlineSlide
K252007 · QIH
Deep Breathe, Inc.
Radiology · 101d
Cleared Sep 29, 2025
SMART PCFD
K250023 · QIH
Disior, Ltd.
Radiology · 269d
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