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
193–216 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 04, 2026
Respiratory Gating for Scanners (2.1)
K253026 · JAK
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Jun 04, 2026
LUNA 3D
K253004 · IYE
Lap GmbH Laser Applikationen
Radiology · 258d
Cleared Jun 03, 2026
HeartFocus
K260780 · QJU
Deski
Radiology · 85d
Cleared Jun 03, 2026
CustoMED Viewer
K260116 · LLZ
CustoMED , Ltd.
Radiology · 140d
Cleared May 29, 2026
OrthoGrid Hip AI® 4.0
K260077 · QIH
OrthoGrid Systems, Inc.
Radiology · 137d
Cleared May 29, 2026
Nexus DRF Digital X-ray Imaging System
K253103 · JAA
Varex Imaging Corporation
Radiology · 247d
Cleared May 29, 2026
HistoSonics® Planning Tool
K252947 · QTZ
HistoSonics, Inc.
Radiology · 256d
Cleared May 28, 2026
ANDI 2.2
K261405 · QIH
Imeka Solutions, Inc.
Radiology · 29d
Cleared May 28, 2026
Bellalun 2D (VDMS-1000S)
K254092 · MUE
Vieworks Co., Ltd.
Radiology · 160d
Cleared May 27, 2026
EPIQ Series Diagnostic Ultrasound Systems
K260680 · IYN
Philips Ultrasound, LLC
Radiology · 86d
Cleared May 27, 2026
Portable Dental X-ray System Model PDX nova
K260367 · EHD
PDX Co., Ltd.
Radiology · 112d
Cleared May 27, 2026
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
K260207 · MUJ
Philips Medical Systems Nederland B.V.
Radiology · 124d
Cleared May 27, 2026
EPIQ Series Diagnostic Ultrasound System
K260123 · IYN
Philips Ultrasound, LLC
Radiology · 132d
Cleared May 27, 2026
Helion Viewer Suite
K254265 · LLZ
Videomed Srl ( a Baxter Healthcare...
Radiology · 148d
Cleared May 27, 2026
Synapse Lung Nodule AI
K254075 · OEB
Fujifilm Corporation
Radiology · 160d
Cleared May 26, 2026
LOGIQ e
K260398 · IYN
GE Medical Systems Ultrasound and...
Radiology · 109d
Cleared May 22, 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K260324 · QIH
Canon Medical Informatics, Inc.
Radiology · 112d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared May 22, 2026
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort...
K253949 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 163d
Cleared May 22, 2026
eXaSkin Plus
K252784 · MUJ
Anatomical Geometry S.L.
Radiology · 262d
Cleared May 22, 2026
C-beam
K252735 · OWB
Pulmera, Inc.
Radiology · 267d
Cleared May 21, 2026
Symbia Pro.specta Q3 (11364751)
K261315 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared CT May 21, 2026
MSK Go
K260234 · QIH
Smart Alfa Teknoloji San. Ve Tic. A.S.
Radiology · 115d
Cleared May 21, 2026
BAC
K254131 · QIH
DeepHealth, Inc.
Radiology · 150d