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
1441–1464 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 08, 2023
PreXion3D Expedition
K232166 · OAS
Prexion Corporation
Radiology · 49d
Cleared Sep 08, 2023
DeepXray
K223621 · QIH
Alpha Intelligence Manifolds, Inc.
Radiology · 277d
Cleared Sep 06, 2023
MAGNETOM Viato.Mobile
K232482 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 21d
Cleared Sep 05, 2023
Promaxo MRI System II
K232361 · LNH
Promaxo, Inc.
Radiology · 29d
Cleared Sep 01, 2023
HyperLight Portable X-ray Unit
K232068 · EHD
Changzhou Sifary Medical Technology...
Radiology · 51d
Cleared Sep 01, 2023
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K232021 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 56d
Cleared Sep 01, 2023
UniSyn Molecular Imaging (6-3-1)
K231047 · LLZ
Convergent Imaging Solutions
Radiology · 142d
Cleared Sep 01, 2023
MasterX 800 Series
K230918 · MQB
Medicatech USA
Radiology · 151d
Cleared Aug 31, 2023
RAYSCAN a-Expert3D
K232287 · OAS
Ray Co., Ltd.
Radiology · 30d
Cleared Aug 30, 2023
Brainomix 360 e-MRI
K231656 · LLZ
Brainomix Limited
Radiology · 84d
Cleared Aug 30, 2023
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
K230355 · LNH
Canon Medical Systems Corporation
Radiology · 202d
Cleared Aug 30, 2023
Mick Valencia Applicator Set
K230155 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 223d
Cleared Aug 28, 2023
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular...
K230221 · IYX
Versant Medical Physics and Radiation...
Radiology · 214d
Cleared Aug 28, 2023
VisAble.IO
K223639 · QTZ
Techsomed
Radiology · 266d
Cleared Aug 25, 2023
AIRAscore
K223180 · LLZ
Airamed GmbH
Radiology · 318d
Cleared CT Aug 25, 2023
BioProtect Balloon Implant™ System
K222972 · OVB
Bioprotect, Ltd.
Radiology · 332d
Cleared Aug 22, 2023
CUPTIMIZE™ Advanced
K231503 · LLZ
DePuy Orthopaedics, Inc.
Radiology · 90d
Cleared Aug 22, 2023
qXR-PTX-PE
K230899 · QFM
Qure.Ai Technologies
Radiology · 144d
Cleared Aug 21, 2023
SM-IV
K232185 · IZL
Sedecal., Sa.
Radiology · 28d
Cleared Aug 21, 2023
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -...
K231731 · KPS
Mcgovern Medical School
Radiology · 69d
Cleared Aug 18, 2023
1.5T HD T/R Knee Array (10-F34127)
K231085 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 123d
Cleared Aug 18, 2023
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the...
K231026 · PGY
Shenzhen Beacon Display Technology...
Radiology · 129d
Cleared Aug 17, 2023
EXTRON 5
K230871 · OWB
DRTECH Corporation
Radiology · 140d
Cleared Aug 16, 2023
TOPA12 Portable X-ray Unit
K230581 · IZL
Neuf, Inc.
Radiology · 167d