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
217–240 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 15, 2024
BriefCase-Quantification
K241112 · QIH
Aidoc Medical , Ltd.
Radiology · 23d
Cleared Apr 25, 2024
InVision Precision LVEF (LVEF)
K232331 · QIH
Invision Medical Technology Corporation
Radiology · 265d
Cleared Apr 17, 2024
uOmnispace.MR
K233186 · QIH
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Apr 04, 2024
Preview Shoulder
K240172 · QIH
Genesis Software Innovations
Radiology · 73d
Cleared Apr 01, 2024
Us2.v2
K233676 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 137d
Cleared Mar 29, 2024
AVIEW CAC
K233211 · QIH
Coreline Soft Co., Ltd.
Radiology · 183d
Cleared Mar 01, 2024
iCAS-LV
K231690 · QIH
Highrad , Ltd.
Radiology · 266d
Cleared Mar 01, 2024
BoneMRI
K233030 · QIH
Mriguidance B.V.
Radiology · 158d
Cleared Feb 29, 2024
inHEART Models
K231683 · QIH
Inheart, Sas
Radiology · 265d
Cleared Feb 28, 2024
CT Cardiomegaly
K232613 · QIH
Innolitics, LLC
Radiology · 184d
Cleared Feb 23, 2024
Overjet Charting Assist
K233590 · QIH
Overjet, Inc.
Radiology · 107d
Cleared Feb 05, 2024
Viz HDS, Viz Volume Plus, Viz ICH+
K232363 · QIH
Viz. Ai, Inc.
Radiology · 182d
Cleared Jan 18, 2024
NemoScan
K232698 · QIH
Software Nemotec S.L.
Radiology · 135d
Cleared Jan 16, 2024
Rapid (6.0)
K233512 · QIH
Ischemaview, Inc.
Radiology · 76d
Cleared Jan 08, 2024
DASI Dimensions (V1.0)
K231324 · QIH
Dasi Simulations
Radiology · 245d
Cleared Jan 05, 2024
VEA Align
K231917 · QIH
Eos Imaging
Radiology · 190d
Cleared Dec 26, 2023
TumorSight Viz
K231130 · QIH
SimBioSys, Inc.
Radiology · 250d
Cleared Dec 18, 2023
iQ-solutions
K231929 · QIH
Sydney Neuroimaging Analysis Centre...
Radiology · 171d
Cleared Dec 13, 2023
QP-Brain®
K232231 · QIH
Quibim S.L.
Radiology · 139d
Cleared Dec 11, 2023
Transpara Density 1.0.0
K232096 · QIH
Screenpoint Medical B.V.
Radiology · 151d
Cleared Dec 08, 2023
Bonelogic
K223757 · QIH
Disior, Ltd.
Radiology · 358d
Cleared Dec 05, 2023
Adravision Perio
K232440 · QIH
Adra Corporation
Radiology · 113d
Cleared Dec 05, 2023
Ceevra Reveal 3+
K233568 · QIH
Ceevra, Inc.
Radiology · 29d
Cleared Dec 01, 2023
Syngo Carbon Clinicals
K232856 · QIH
Siemens Healthcare GmbH
Radiology · 77d