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
625–648 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 03, 2025
syngo.via MI Workflows
K251528 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Jul 03, 2025
SOMATOM go.Now
K250822 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 107d
Cleared Jul 03, 2025
MammoScreen® (4)
K243679 · QDQ
Therapixel
Radiology · 216d
Cleared Jul 02, 2025
Orthoscan TAU Mini C-Arm
K250587 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 125d
Cleared Jul 02, 2025
Mendaera Guidance System
K250524 · ITX
Mendaera, Inc.
Radiology · 131d
Cleared Jul 02, 2025
Leksell Gamma Knife® (Elekta Esprit)
K250391 · IWB
Elekta Solutions AB
Radiology · 140d
Cleared Jul 01, 2025
StrokeSENS ASPECTS Software Application
K250221 · POK
Circle Cardiovascular Imaging, Inc.
Radiology · 158d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 30, 2025
PIUR tUS inside
K250484 · QIH
Piur Imaging GmbH
Radiology · 131d
Cleared Jun 30, 2025
Synapse PACS (7.5)
K243647 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 216d
Cleared Jun 27, 2025
Dental CBCT X-ray System
K251642 · OAS
Yian Medical Technology (Haining)...
Radiology · 29d
Cleared Jun 27, 2025
Philips iCT CT system
K250648 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 115d
Cleared Jun 27, 2025
eMotus Respiratory Motion Management System
K243900 · LHN
Empnia, Inc.
Radiology · 190d
Cleared Jun 26, 2025
Velacur One (LI-1100)
K251728 · IYO
Sonic Incytes Medical Corp
Radiology · 21d
Cleared Jun 23, 2025
Cranial 4Pi Immobilization
K243142 · IYE
Brainlab AG
Radiology · 266d
Cleared Jun 20, 2025
CT Scanner TSX-501R/1 V11.1
K243398 · JAK
Canon Medical Systems Corporation
Radiology · 232d
Cleared Jun 18, 2025
EPIQ Series Diagnostic Ultrasound Systems
K250886 · IYN
Philips Ultrasound, LLC
Radiology · 85d
Cleared Jun 18, 2025
CardIQ Suite
K243672 · JAK
GE Medical Systems SCS
Radiology · 203d
Cleared Jun 18, 2025
6600 Ultrasound System (MyLabA50)
K243253 · IYN
Esaote, S.P.A.
Radiology · 246d
Cleared Jun 17, 2025
SKR 3000
K250665 · MQB
Konica Minolta, Inc.
Radiology · 104d
Cleared Jun 17, 2025
RT Elements (4.5)
K250440 · MUJ
Brainlab AG
Radiology · 123d
Cleared Jun 17, 2025
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990,...
K243880 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 181d
Cleared Jun 17, 2025
uOmniscan
K243666 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 202d