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
553–576 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 10, 2025
Viz Subdural+, Viz SUBDURAL PLUS
K250354 · QIH
Viz. Ai, Inc.
Radiology · 123d
Cleared Jun 10, 2025
EXTRON 3
K250010 · OWB
DRTECH Corporation
Radiology · 159d
Cleared Jun 06, 2025
Cirrus Resting State fMRI Software
K251009 · QIH
Sora Neuroscience, Inc.
Radiology · 66d
Cleared Jun 05, 2025
BrightHeart View Classifier
K251456 · QIH
Brightheart
Radiology · 24d
Cleared Jun 05, 2025
UroNav 4
K250800 · LLZ
Philips DS North America, LLC
Radiology · 83d
Cleared Jun 05, 2025
TechLive
K243703 · LLZ
DeepHealth, Inc.
Radiology · 188d
Cleared Jun 05, 2025
Sonic DL
K243667 · LNH
Ge Medical Systems, LLC
Radiology · 190d
Cleared Jun 04, 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and...
K251397 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jun 04, 2025
TraumaCad Neo (1.1)
K243810 · QIH
Brainlab , Ltd.
Radiology · 175d
Cleared May 30, 2025
BriefCase-Triage
K251406 · QAS
Aidoc Medical , Ltd.
Radiology · 24d
Cleared May 30, 2025
Swoop® Portable MR Imaging® System (V2)
K250236 · LNH
Hyperfine, Inc.
Radiology · 123d
Cleared May 30, 2025
TE Air Diagnostic Ultrasound System
K250024 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 144d
Cleared May 30, 2025
Opulus™ Lymphoma Precision
K243863 · QIH
Roche Molecular Systems, Inc.
Radiology · 164d
Cleared May 30, 2025
AudaxCeph Cephalogram Analysis Software
K243005 · QIH
Audax D.O.O.
Radiology · 246d
Not Cleared May 30, 2025
Allix5
DEN240047 · SEZ
Clairity, Inc.
Radiology · 266d
Cleared May 29, 2025
Voluson™ Performance 16
K250543 · IYN
GE Medical Systems Ultrasound and...
Radiology · 94d
Cleared May 28, 2025
TAIMedImg DeepMets
K250427 · QKB
Taiwan Medical Imaging Co., Ltd.
Radiology · 103d
Cleared May 28, 2025
CoLumboX
K250367 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared May 28, 2025
Europa (Alternative: AiRTouch) portable X-ray system
K244049 · IZL
Livermoretech, Inc.
Radiology · 148d
Cleared May 28, 2025
Rapid MLS
K243378 · QIH
Ischemaview, Inc.
Radiology · 210d
Cleared May 23, 2025
Clever One
K250005 · QIH
Ewoosoft Co., Ltd.
Radiology · 141d
Cleared May 23, 2025
Second Opinion® 3D
K243989 · QIH
Pearl, Inc.
Radiology · 148d
Cleared May 23, 2025
Accuro 3S
K243937 · IYO
Rivanna Medical, Inc.
Radiology · 154d
Cleared May 23, 2025
DEEPECHO
K242594 · IYN
Deepecho
Radiology · 266d