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
4201–4224 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 05, 2016
SyncVision System
K161756 · OWB
Volcano Corporation
Radiology · 70d
Cleared Sep 02, 2016
Restore PACS
K162141 · LLZ
Xian Wingspan Electronic Technology...
Radiology · 32d
Cleared Sep 02, 2016
MyLabSix Ultrasound System
K161168 · IYN
Esaote Europe B.V.
Radiology · 129d
Cleared Sep 02, 2016
PROcedure Rehearsal Studio
K153705 · LLZ
3Dsystems, Simbionix Products
Radiology · 254d
Cleared Sep 01, 2016
CareView 1500P X-ray Flat Panel Detectors
K162178 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 28d
Cleared Sep 01, 2016
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
K161942 · MQB
Perkinelmer, Inc.
Radiology · 48d
Cleared Sep 01, 2016
SIGNA Voyager
K161567 · LNH
Ge Healthcare
Radiology · 86d
Cleared Sep 01, 2016
EzRay Air (Model VEX-P300)
K161063 · EHD
VATECH Co., Ltd.
Radiology · 139d
Cleared Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · MOS
Invivo Corporation
Radiology · 42d
Cleared Aug 31, 2016
Vscan Extend
K161588 · IYN
GE Medical Systems Ultrasound &...
Radiology · 84d
Cleared Aug 31, 2016
MAGiC
K161397 · LNH
Ge Medical Systems, LLC
Radiology · 104d
Cleared Aug 30, 2016
OnSight 3D Extremity System
K160723 · JAK
Carestream Health, Inc.
Radiology · 167d
Cleared Aug 26, 2016
RS80A Diagnostic Ultrasound System
K162094 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Aug 25, 2016
AneurysmFlow
K160455 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 189d
Cleared Aug 24, 2016
SOMATOM Drive
K161196 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Aug 24, 2016
ResolutionMD
K161130 · LLZ
Calgary Scientific, Inc.
Radiology · 125d
Cleared Aug 23, 2016
Vantage Titan 1.5T, MRT-1510, V3.6 Software
K160632 · LNH
Toshibamedical Systems Corporation
Radiology · 169d
Cleared Aug 18, 2016
Sentinella 102, Sentinella 102 Horus
K162052 · IYX
General Equipment For Medical Imaging...
Radiology · 24d
Cleared Aug 18, 2016
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Aug 17, 2016
SUPRIA w/guideShot Option
K161748 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared Aug 17, 2016
PACS CORE/ENCORE
K161518 · LLZ
Compania Mexicana DE Radiologia Cgr,...
Radiology · 76d
Cleared Aug 17, 2016
SPEC Model M23
K161396 · KXK
Source Production and Equipment Co.,...
Radiology · 90d
Cleared Aug 17, 2016
Uroview FD
K161019 · JAA
Pausch Medical GmbH
Radiology · 127d
Cleared Aug 17, 2016
Sumitomo Proton Therapy System
K160612 · LHN
Sumitomo Heavy Industries, Ltd.
Radiology · 167d