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 ×
15,695 results
673–696 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 21, 2025
Swoop® Portable MR Imaging® System
K251276 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared May 21, 2025
SMARTDent
K251109 · LLZ
Ray Co., Ltd.
Radiology · 40d
Cleared May 21, 2025
EPIQ Series Diagnostic Ultrasound System
K243793 · IYN
Philips Ultrasound, LLC
Radiology · 162d
Cleared May 21, 2025
Synapse 3D Base Tools (V7.0)
K243762 · QIH
Fujifilm Corporation
Radiology · 166d
Cleared May 21, 2025
uMR Omega
K243122 · LNH
Shanghai United Imaging Healthcare...
Radiology · 233d
Cleared May 20, 2025
SCENARIA View Phase 5.0
K250370 · JAK
Fujifilm Corporation
Radiology · 99d
Cleared May 19, 2025
Diagnostic Ultrasound System (Recho R9W)
K250020 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 136d
Cleared May 19, 2025
Diagnostic X-ray System
K243411 · OWB
Nanjing Perlove Medical Equipment...
Radiology · 199d
Cleared May 19, 2025
MapRT
K243301 · IYE
Vision Rt, Ltd.
Radiology · 213d
Cleared May 16, 2025
Diagnostic Ultrasound System (MX6)
K250110 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 120d
Cleared May 16, 2025
Mobius3D (4.1)
K250099 · IYE
Varian Medical Systems
Radiology · 122d
Cleared May 16, 2025
Spectral CT
K244008 · JAK
Philips Medical Systems Technologies...
Radiology · 141d
Cleared May 16, 2025
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · JAK
Shanghai United Imaging Healthcare...
Radiology · 175d
Cleared May 16, 2025
MasteRad MiniX Mobile Digital Imaging System (Mini-X)
K242731 · OWB
Medicatech USA, Inc.
Radiology · 248d