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
289–312 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 08, 2022
ClearPoint Maestro Brain Model
K213645 · QIH
ClearPoint Neuro, Inc.
Radiology · 263d
Cleared Aug 03, 2022
Customize
K221432 · QIH
3D-Side S.A.
Radiology · 78d
Cleared Jul 28, 2022
cvi42 Auto Imaging Software Application
K213998 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 219d
Cleared Jul 22, 2022
EchoPAC Software Only, EchoPAC Plug-in
K220940 · QIH
GE Medical Systems Ultrasound and...
Radiology · 113d
Cleared Jul 20, 2022
Libby Echo:Prio
K220956 · QIH
Dyad Medical, Inc.
Radiology · 110d
Cleared Jul 19, 2022
BrainInsight
K220815 · QIH
Hyperfine, Inc.
Radiology · 120d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Apr 15, 2022
AI-Rad Companion Brain MR
K213706 · QIH
Siemens Healthcare GmbH
Radiology · 142d
Cleared Apr 04, 2022
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
K212624 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 229d
Cleared Mar 16, 2022
Customize
K213779 · QIH
3D-Side S.A.
Radiology · 103d
Cleared Mar 14, 2022
Arterys MICA
K203744 · QIH
Arterys, Inc.
Radiology · 447d
Cleared Jan 19, 2022
Caption Interpretation Automated Ejection Fraction Software
K210747 · QIH
Caption Health
Radiology · 313d
Cleared Jan 19, 2022
Follicle Clarity
K212012 · QIH
Cycle Clarity
Radiology · 205d
Cleared Jan 06, 2022
TOMTEC-ARENA
K213544 · QIH
Tomtec Imaging Systems GmbH
Radiology · 59d
Cleared Dec 22, 2021
BoneMRI
K202404 · QIH
Mriguidance B.V.
Radiology · 488d
Cleared Dec 21, 2021
qXR-BT
K212690 · QIH
Qure.Ai Technologies
Radiology · 118d
Cleared Dec 20, 2021
EchoGo Core (2.0)
K213275 · QIH
Ultromics Limited
Radiology · 81d
Cleared Dec 09, 2021
LVivo Seamless
K212466 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 125d
Cleared Nov 19, 2021
OnQ Neuro
K210831 · QIH
Cortechs Labs, Inc.
Radiology · 245d
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Sep 10, 2021
ClariSIGMAM
K203785 · QIH
Claripi, Inc.
Radiology · 256d
Cleared Sep 08, 2021
AmCAD-UT
K203555 · QIH
Amcad Biomed Corporation
Radiology · 275d
Cleared Aug 02, 2021
breastscape v1.0
K211431 · QIH
Olea Medical
Radiology · 87d
Cleared Jul 30, 2021
qER-Quant
K211222 · QIH
Qure.Ai Technologies
Radiology · 98d