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: Radiology ×
15,589 results
529–552 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 16, 2025
Methinks NCCT Stroke
K250685 · QAS
Methinks Software, S.L
Radiology · 102d
Cleared Jun 16, 2025
MAGNETOM Avanto Fit
K250443 · LNH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jun 16, 2025
MAGNETOM Flow.Ace
K250436 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 122d
Cleared Jun 16, 2025
Mosaic (V1.0.1)
K244012 · LLZ
Navier Medical
Radiology · 172d
Cleared Jun 13, 2025
Accuro® 3S Needle Guide Kit
K250469 · ITX
Rivanna Medical, Inc.
Radiology · 115d
Cleared Jun 13, 2025
Brainlab Elements (7.0)
K243633 · QIH
Brainlab AG
Radiology · 200d
Cleared Jun 12, 2025
Aurora
K251153 · KPS
Ge Medical Systems Israel
Radiology · 59d
Cleared Jun 12, 2025
Second Opinion® CS
K243234 · MYN
Pearl, Inc.
Radiology · 245d