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
1489–1512 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 20, 2023
uOmnispace
K230039 · QIH
Shanghai United Imaging Healthcare...
Radiology · 195d
Cleared Jul 20, 2023
AccuCheck
K223834 · IYE
Manteia Technologies Co., Ltd.
Radiology · 210d
Cleared Jul 20, 2023
IGAR System (1001.A)
K223484 · MOS
Insight Medbotics, Inc.
Radiology · 244d
Cleared Jul 19, 2023
Grreen X 12 (Model: PHT-75CHS)
K231796 · OAS
VATECH Co., Ltd.
Radiology · 29d
Cleared Jul 19, 2023
syngo.CT Lung CAD (Version VD30)
K231157 · OEB
Siemens Healthcare GmbH
Radiology · 86d
Cleared Jul 17, 2023
Fibroid Mapping Reviewer Application (FMRA)
K222683 · LLZ
Nesa Medtech Private Limited
Radiology · 314d
Cleared Jul 14, 2023
Ez3D-i /E3
K231757 · QIH
Ewoosoft Co., Ltd.
Radiology · 28d
Cleared Jul 14, 2023
JiveX (Model Number / Release: 5.4)
K231041 · LLZ
Visus Health IT GmbH
Radiology · 93d
Cleared Jul 14, 2023
Cercare Medical Neurosuite
K230016 · LLZ
Cercare Medical A/S
Radiology · 192d
Cleared Jul 14, 2023
Brainlab Elements Image Fusion, Contouring (4.5)
K223106 · QIH
Brainlab AG
Radiology · 287d
Cleared Jul 13, 2023
Biograph Vision.X and Biograph Vision.X Edge
K231833 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 21d
Cleared Jul 13, 2023
Portable X-ray System Model Ray98(P)
K231449 · EHD
Ningbo Runyes Medical Instrument Co.,...
Radiology · 56d
Cleared Jul 13, 2023
Chondral Quant
K231351 · LLZ
Siemens Medical Soultions USA, Inc.
Radiology · 65d
Cleared Jul 13, 2023
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
K230611 · JAD
Xstrahl, Ltd.
Radiology · 129d
Cleared Jul 13, 2023
ECHELON Synergy MRI system
K223426 · LNH
Fujifilm Healthcare Corporation
Radiology · 241d
Cleared Jul 13, 2023
Spine Auto Views
K223424 · JAK
GE Medical Systems SCS
Radiology · 241d
Cleared Jul 13, 2023
Open Rib
K223261 · JAK
Canon Medical Informatics, Inc.
Radiology · 262d