FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
3409–3432 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 10, 2018
Portable X-ray System (Model: MiniX-V, Mini X-S)
K181891 · EHD
Digimed Co., Ltd.
Radiology · 28d
Cleared Aug 07, 2018
CubeVue
K181962 · LLZ
Curvebeam, LLC
Radiology · 15d
Cleared Aug 07, 2018
AlignRT Plus
K181218 · IYE
Vision Rt, Ltd.
Radiology · 92d
Cleared Aug 07, 2018
Model WP-3840 and WP-3040
K173848 · IYE
Cnmc Co., Inc.
Radiology · 231d
Cleared Aug 03, 2018
Philips CT Big Bore Sliding Gantry Configuration
K181797 · JAK
Phillips Medical Systems (Cleveland),...
Radiology · 29d
Cleared Aug 03, 2018
Ingenia Ambition S and Ingenia Ambition X
K181479 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Aug 03, 2018
VirtuOst Vertebral Fracture Assessment
K171435 · LLZ
O.N. Diagnostics, LLC
Radiology · 445d
Cleared Aug 02, 2018
Azurion R2.0
K181830 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 24d
Cleared Aug 02, 2018
Alphenix, INFX-8000C/B, V8.0
K181804 · OWB
Canon Medical Systems Corporation
Radiology · 27d
Cleared Aug 02, 2018
ProVectra 3D Prime with VistaSoft
K181432 · OAS
Durr Dental SE
Radiology · 62d
Cleared Aug 02, 2018
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
K171977 · LLZ
Hinacom Software and Technology, Ltd.
Radiology · 398d
Cleared Aug 01, 2018
Ultrasound Scanner System bk2300
K180737 · IYN
Bk Medical Aps
Radiology · 132d
Cleared Aug 01, 2018
BriefCase
K180647 · QAS
Aidoc Medical , Ltd.
Radiology · 142d
Cleared Jul 30, 2018
TE7/TE5 Diagnostic Ultrasound System
K180912 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 115d
Cleared Jul 27, 2018
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic...
K181485 · IYN
Philips Ultrasound, Inc.
Radiology · 51d
Cleared Jul 27, 2018
RCT800
K181452 · OAS
Ray Co., Ltd.
Radiology · 56d
Cleared Jul 25, 2018
Alphenix, INFX-8000V/B, V8.0
K181670 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Jul 23, 2018
Quantitative Total Extensible Imaging (QTxI)
K173444 · LLZ
Aiq Solutions, Inc.
Radiology · 259d
Cleared Jul 20, 2018
Aurora
K181636 · MUH
Sodium Systems, LLC
Radiology · 29d
Cleared Jul 20, 2018
GR40CW
K181631 · MQB
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
GC85A
K181629 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
Digital Diagnostic Mobile X-ray System
K181626 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 19, 2018
Ultimax-i, DREX-UI80 (V1.60)
K181834 · OWB
Canon Medical Systems Corporation
Radiology · 9d
Cleared Jul 19, 2018
DentiqGuide
K180629 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 132d