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
145–168 of 313
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 22, 2025
Rapid Neuro3D
K243350 · QIH
Ischemaview, Inc.
Radiology · 86d
Cleared Jan 02, 2025
Ortho AI
K241696 · QIH
Ortho Ai, LLC
Radiology · 204d
Cleared Jan 02, 2025
Ezra Flash
K242334 · QIH
Ezra Ai, Inc.
Radiology · 148d
Cleared Dec 19, 2024
OrthoNext Platform System
K242270 · QIH
Orthofix Srl
Radiology · 140d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 16, 2024
MSKai
K240793 · QIH
Mskai
Radiology · 269d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Intuitive Surgical, Inc.
Radiology · 113d
Cleared Dec 06, 2024
CDM Insights
K240680 · QIH
Oxford Brain Diagnostics, Ltd.
Radiology · 270d
Cleared Dec 06, 2024
DrAid™ for Liver Segmentation
K241543 · QIH
Vinbrain Joint Stock Company
Radiology · 189d
Cleared Nov 27, 2024
Sonix Health
K240645 · QIH
Ontact Health Co., Ltd.
Radiology · 265d
Cleared Nov 22, 2024
BriefCase-Quantification
K242203 · QIH
Aidoc Medical , Ltd.
Radiology · 119d
Cleared Nov 20, 2024
Strain AI (SAI001)
K242359 · QIH
Exo, Inc.
Radiology · 103d
Cleared Nov 05, 2024
TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312 · QIH
Terarecon,Inc.
Radiology · 180d
Cleared Oct 30, 2024
RemedyLogic AI MRI Lumbar Spine Reader
K241108 · QIH
Remedy Logic, Inc.
Radiology · 191d
Cleared Oct 25, 2024
Neurophet AQUA (V3.1)
K242215 · QIH
Neurophet., Inc.
Radiology · 88d
Cleared Oct 25, 2024
TumorSight Viz
K243189 · QIH
SimBioSys, Inc.
Radiology · 25d
Cleared Oct 15, 2024
cvi42 Software Application
K242781 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 29d
Cleared Oct 10, 2024
AutoChamber
K240786 · QIH
HeartLung Corporation
Radiology · 202d
Cleared Oct 10, 2024
EchoMeasure
K241430 · QIH
Icardio.Ai
Radiology · 142d
Cleared Oct 04, 2024
LVivo Software Application
K240553 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 219d
Cleared Oct 02, 2024
MammoScreen BD
K241561 · QIH
Therapixel
Radiology · 124d
Cleared Oct 01, 2024
LungVision
K240943 · QIH
Bodyvision Medical , Ltd.
Radiology · 179d
Cleared Sep 20, 2024
PIUR tUS Infinity
K240036 · QIH
Piur Imaging GmbH
Radiology · 259d
Cleared Sep 12, 2024
Constellation (CON-001)
K241280 · QIH
Q Bio, Inc.
Radiology · 128d