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
241–264 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 28, 2023
syngo.via MI Workflows
K232000 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Nov 17, 2023
AI Platform (AIP001)
K232501 · QIH
Exo, Inc.
Radiology · 92d
Cleared Nov 15, 2023
Axial3D Insight
K232841 · QIH
Axial Medical Printing Limited
Radiology · 62d
Cleared Nov 13, 2023
BriefCase-Quantification
K232083 · QIH
Aidoc Medical , Ltd.
Radiology · 123d
Cleared Nov 13, 2023
Clarius Bladder AI
K232257 · QIH
Clarius Mobile Health Corp.
Radiology · 108d
Cleared Nov 08, 2023
BriefCase-Quantification
K230534 · QIH
Aidoc Medical , Ltd.
Radiology · 254d
Cleared Nov 03, 2023
aprevo® Digital Segmentation
K231955 · QIH
Carlsmed, Inc.
Radiology · 123d
Cleared Oct 23, 2023
AI-Rad Companion Brain MR
K232305 · QIH
Siemens Medical Solutions U.S.A.
Radiology · 83d
Cleared Oct 20, 2023
Sonix Health
K230209 · QIH
Ontact Health Co., Ltd.
Radiology · 268d
Cleared Oct 05, 2023
cmAngio® V1.0
K232367 · QIH
Curemetrix, Inc.
Radiology · 58d
Cleared Oct 04, 2023
VUNO Med-DeepBrain
K231398 · QIH
Vuno, Inc.
Radiology · 142d
Cleared Sep 29, 2023
HipCheck
K230045 · QIH
Stryker Corp.
Radiology · 266d
Cleared Sep 22, 2023
qXR-CTR
K231149 · QIH
Qure.Ai Technologies
Radiology · 154d
Cleared Sep 08, 2023
DeepXray
K223621 · QIH
Alpha Intelligence Manifolds, Inc.
Radiology · 277d
Cleared Jul 25, 2023
ANDI
K230913 · QIH
Imeka Solutions, Inc.
Radiology · 116d
Cleared Jul 21, 2023
OptimMRI
K230150 · QIH
Rebrain, Sas
Radiology · 183d
Cleared Jul 20, 2023
uOmnispace
K230039 · QIH
Shanghai United Imaging Healthcare...
Radiology · 195d
Cleared Jul 14, 2023
Brainlab Elements Image Fusion, Contouring (4.5)
K223106 · QIH
Brainlab AG
Radiology · 287d
Cleared Jul 14, 2023
Ez3D-i /E3
K231757 · QIH
Ewoosoft Co., Ltd.
Radiology · 28d
Cleared Jul 07, 2023
Spine CAMP™ (1.1)
K231668 · QIH
Medical Metrics, Inc.
Radiology · 30d
Cleared Jul 03, 2023
Axial3D Insight
K222745 · QIH
Axial Medical Printing Limited
Radiology · 294d
Cleared Jun 22, 2023
Bladder AI (AIBV01)
K230497 · QIH
Exo, Inc.
Radiology · 118d
Cleared Jun 16, 2023
DeepCatch
K223556 · QIH
Medical IP Co., Ltd.
Radiology · 200d
Cleared Jun 16, 2023
IB Lab LAMA
K223646 · QIH
Ib Lab GmbH
Radiology · 192d