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: Radiology × Cleared only ×
15,676 results
1465–1488 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 15, 2023
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
K232127 · PGY
Lg Electronics.Inc
Radiology · 29d
Cleared Aug 15, 2023
Vscan Air
K231301 · IYN
GE Medical Systems Ultrasound and...
Radiology · 102d
Cleared Aug 15, 2023
Annalise Enterprise CTB Triage-OH
K231094 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 119d
Cleared Aug 14, 2023
SaintView
K223660 · LLZ
Inviz Corporation
Radiology · 251d
Cleared Aug 10, 2023
Aura 10 PET/CT
K231420 · QXL
Xeos Medical
Radiology · 86d
Cleared Aug 08, 2023
Efai Pacs Picture Archiving and Communication System Pro
K232100 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 25d
Cleared Aug 03, 2023
YosemiteView 4343W/YosemiteView 3643W
K232058 · MQB
Careray Digital Medical Technology...
Radiology · 23d
Cleared Aug 03, 2023
VisiRad XR
K223133 · MYN
Imidex, Inc.
Radiology · 304d
Cleared Aug 02, 2023
Ingenia Elition R5.7.1 SP4 MR Systems
K232030 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 26d
Cleared Aug 02, 2023
Disposable Needle Guides and Grids
K223689 · ITX
Advance Medical Designs, Inc.
Radiology · 236d
Cleared Aug 01, 2023
EXPD 4357
K231959 · MQB
DRTECH Corporation
Radiology · 29d
Cleared Aug 01, 2023
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy...
K230162 · JAK
Shanghai United Imaging Healthcare...
Radiology · 193d
Cleared Jul 27, 2023
Brainomix 360 Triage ICH
K231195 · QAS
Brainomix Limited
Radiology · 91d
Cleared Jul 27, 2023
Rapid Aneurysm Triage and Notification
K230074 · QFM
Ischemaview, Inc.
Radiology · 198d
Cleared Jul 26, 2023
uMI Panorama
K231572 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Jul 25, 2023
MOBILETT Impact
K231577 · IZL
Siemens Medical Solutions
Radiology · 55d
Cleared Jul 25, 2023
ANDI
K230913 · QIH
Imeka Solutions, Inc.
Radiology · 116d
Cleared Jul 25, 2023
IDENTIFY
K230576 · IYE
Varian Medical Systems, Inc.
Radiology · 146d
Cleared Jul 25, 2023
Patient Specific Planning Solution™ 3D Bone Models
K230540 · LLZ
Biomet Manufacturing Corp
Radiology · 148d
Cleared Jul 25, 2023
Sonio Detect
K230365 · IYN
Sonio
Radiology · 165d
Cleared Jul 24, 2023
UltraSight AI Guidance
K223347 · QJU
Ultrasight, Inc.
Radiology · 265d
Cleared Jul 24, 2023
Argus Cognitive ReVISION Software
K223322 · LLZ
Argus Cognitive, Inc.
Radiology · 266d
Cleared Jul 21, 2023
OptimMRI
K230150 · QIH
Rebrain, Sas
Radiology · 183d
Cleared Jul 20, 2023
Oscar 15 & Oscar 15i
K230787 · OWB
Genoray Co., Ltd.
Radiology · 120d