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
1489–1512 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 13, 2023
XR90 (XR90-SYS)
K223125 · LLZ
Mediview Xr, Inc.
Radiology · 283d
Cleared Jul 12, 2023
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
K231709 · MQB
Radmedix, LLC
Radiology · 30d
Cleared Jul 10, 2023
Ziehm Vision RFD 3D
K231701 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Jul 10, 2023
MOZI TPS
K223724 · MUJ
Manteia Technologies Co., Ltd.
Radiology · 209d
Cleared Jul 10, 2023
X-View 3D Pan/X-View 2D Pan
K222666 · OAS
Trident S.R.L
Radiology · 307d
Cleared Jul 07, 2023
Spine CAMP™ (1.1)
K231668 · QIH
Medical Metrics, Inc.
Radiology · 30d
Cleared Jul 07, 2023
Bladder Scanner Model: BVT02
K223448 · IYO
Xuzhou Kaixin Electronic Instrument...
Radiology · 234d