FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,570 results
481–504 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 30, 2025
Voxel Dosimetry (00859873006226)
K243919 · QIH
Hermes Medical Solutions AB
Radiology · 222d
Cleared Jul 29, 2025
Cios Spin
K251523 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 29, 2025
PRORAD ATLAS ULTRAPORTABLE
K243473 · IZL
Prognosys Medical Systems Private...
Radiology · 263d
Cleared Jul 28, 2025
NAEOTOM Alpha.Peak/NAEOTOM Alpha
K251061 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Jul 25, 2025
Venue
K251322 · IYN
GE Medical Systems Ultrasound and...
Radiology · 87d
Cleared Jul 25, 2025
Marie
K250970 · JAK
Leo Cancer Care
Radiology · 116d
Cleared Jul 24, 2025
EPIQ Series Diagnostic Ultrasound System
K251455 · IYN
Philips Ultrasound, LLC
Radiology · 73d
Cleared Jul 23, 2025
IMAGE ONE
K250716 · LLZ
Infomed Software, S.L.
Radiology · 135d
Cleared Jul 23, 2025
Neuro Insight V1.0
K243681 · LLZ
Olea Medical S.A.S.
Radiology · 236d
Cleared Jul 22, 2025
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K250901 · LNH
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jul 22, 2025
GyriCalc (Version 1.0.0)
K250686 · LLZ
Neurospectrum Insights Corp.
Radiology · 138d
Cleared Jul 22, 2025
Yushan X-Ray Flat Panel Detector
K250211 · MQB
Innocare Optoelectronics Corp.
Radiology · 179d
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