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
601–624 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 22, 2025
Vascular Navigation PAD 2.0
K243432 · OWB
Brainlab AG
Radiology · 259d
Cleared Jul 18, 2025
V8 Diagnostic Ultrasound System
K250999 · IYN
Samsung Medison Co., Ltd.
Radiology · 108d
Cleared Jul 18, 2025
HeartFlow Analysis
K250902 · PJA
HeartFlow, Inc.
Radiology · 114d
Cleared Jul 18, 2025
INNOVISION-P5
K250750 · IZL
Dk Medical Systems Co., Ltd.
Radiology · 128d
Cleared Jul 17, 2025
uMI Panvivo (uMI Panvivo)
K251839 · KPS
Shanghai United Imaging Healthcare...
Radiology · 31d
Cleared Jul 17, 2025
uMR Ultra
K243547 · LNH
Shanghai United Imaging Healthcare...
Radiology · 244d
Cleared Jul 17, 2025
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G...
K243428 · MOS
Dxtx Medical, Inc.
Radiology · 254d
Cleared Jul 17, 2025
HESTIA
K243420 · MUE
Genoray Co., Ltd.
Radiology · 255d
Cleared Jul 16, 2025
EchoPAC Software Only / EchoPAC Plug-in
K251342 · QIH
GE Medical Systems Ultrasound and...
Radiology · 77d
Cleared Jul 16, 2025
Rapid CTA 360
K251151 · QAS
Ischemaview
Radiology · 93d
Cleared Jul 16, 2025
uMR 680
K243397 · LNH
Shanghai United Imaging Healthcare...
Radiology · 258d
Cleared Jul 15, 2025
AV Viewer
K250181 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Cleared Jul 15, 2025
IsoSphere
K242818 · KXK
Isoaid, LLC
Radiology · 300d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 14, 2025
LUMINOS Q.namix T
K250660 · OWB
Siemens Medical Solutions
Radiology · 131d
Cleared Jul 14, 2025
GECHO
K250120 · LLZ
Narnar, LLC
Radiology · 179d
Cleared Jul 11, 2025
Achieva
K251808 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared Jul 11, 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
K250762 · ITX
Olympus Medical Systems Corporation
Radiology · 120d
Cleared Jul 11, 2025
B-Scan
K243227 · IYO
Accutome, Inc. Doing Business AS...
Radiology · 276d
Cleared Jul 10, 2025
Sonosite LX Ultrasound System
K251830 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jul 10, 2025
Vivid Pioneer
K251169 · IYN
GE Medical Systems Ultrasound and...
Radiology · 86d
Cleared Jul 09, 2025
Cios Alpha
K251520 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Jul 08, 2025
TumorSight Viz
K251766 · QIH
SimBioSys, Inc.
Radiology · 29d
Cleared Jul 07, 2025
CustomSurg OrthoPlanner
K251863 · LLZ
Customsurg AG
Radiology · 20d