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
313–334 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 27, 2021
Us2.v1
K210791 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 133d
Cleared Jul 20, 2021
Change Healthcare Anatomical AI
K210719 · QIH
Change Healthcare Canada Company
Radiology · 132d
Cleared Jul 12, 2021
PowerLook Density Assessment V4.0
K211506 · QIH
Icad, Inc.
Radiology · 59d
Cleared Jun 10, 2021
syngo.via MI WorkFlows, Scenium, syngo MBF
K211459 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Apr 23, 2021
MEDO-Thyroid
K203502 · QIH
Medo DX Pte. , Ltd.
Radiology · 144d
Cleared Apr 21, 2021
Preview Shoulder
K210556 · QIH
Genesis Software Innovations
Radiology · 55d
Cleared Mar 09, 2021
Imbio RV/LV Software
K203256 · QIH
Imbio, LLC
Radiology · 125d
Cleared Feb 05, 2021
LVivo Software Application
K210053 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 28d
Cleared Jan 29, 2021
Visage Breast Density
K201411 · QIH
Visage Imaging GmbH
Radiology · 246d
Cleared Nov 18, 2020
syngo.via MI Workflows, syngo MBF
K201195 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared Oct 30, 2020
WRDensity by Whiterabbit.ai
K202013 · QIH
Whiterabbit.Ai, Inc.
Radiology · 101d
Cleared Sep 29, 2020
LVivo Seamless
K202546 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 27d
Cleared Jul 30, 2020
AI-Rad Companion Prostate MR
K193283 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 246d
Cleared Jul 22, 2020
Caption Interpretation Automated Ejection Fraction Software
K200621 · QIH
Caption Health
Radiology · 135d
Cleared Jul 10, 2020
Ezra Plexo Software
K192969 · QIH
Ezra Ai, Inc.
Radiology · 261d
Cleared Jun 23, 2020
LVivo Software Application
K200232 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 145d
Cleared Jun 11, 2020
MEDO ARIA
K200356 · QIH
Medo.Ai
Radiology · 119d
Cleared Jun 03, 2020
QLAB Advanced Quantification Software
K200974 · QIH
Philips Health Care
Radiology · 51d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Shanghai United Imaging Healthcare...
Radiology · 255d
Cleared Mar 25, 2020
Arterys MICA
K192437 · QIH
Arterys, Inc.
Radiology · 201d
Cleared Dec 20, 2019
QLAB Advanced Quantification Software
K191647 · QIH
Philips Health Care
Radiology · 183d
Cleared Nov 13, 2019
EchoGo Core
K191171 · QIH
Ultromics, Ltd.
Radiology · 196d