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
265–288 of 313
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 27, 2022
NS-HGlio
K221738 · QIH
Neosoma, Inc.
Radiology · 104d
Cleared Aug 29, 2022
Viz RV/LV
K221100 · QIH
Viz. Ai, Inc.
Radiology · 137d
Cleared Aug 19, 2022
MI View&GO
K222172 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
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