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
4753–4776 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 02, 2015
TRILLIUM Oval MR System
K142734 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 160d
Cleared Feb 24, 2015
Syngo X-workplace SW VD10
K143319 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 97d
Cleared Feb 24, 2015
THD REVOLUTION
K141657 · JAF
Thd Spa
Radiology · 249d
Cleared Feb 20, 2015
Terason uSmart3300 Ultrasound System
K150148 · IYN
Teratech Corp.
Radiology · 28d
Cleared Feb 20, 2015
Volcano iFR Harvest Software (Offline)
K143122 · IYO
Volcano Corporation
Radiology · 112d
Cleared Feb 20, 2015
U50 Diagnostic Ultrasound System
K142511 · IYN
Edan Instruments, Inc.
Radiology · 165d
Cleared Feb 19, 2015
GM60A-32S & GM60A-40S
K150097 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Feb 19, 2015
Vienna System
K142597 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Feb 18, 2015
Optima XR646
K143270 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 97d
Cleared Feb 13, 2015
TOMTEC-ARENA TTA2
K150122 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 24d
Cleared Feb 10, 2015
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
K142472 · IYN
Ge Healthcare
Radiology · 160d
Cleared Feb 09, 2015
ACUSON P500 Diagnostic Ultrasound System
K150050 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Feb 06, 2015
MD322C8 31.5 Diagnostic Imaging LCD Monitor
K150145 · PGY
Nec Display Solutions , Ltd.
Radiology · 15d
Cleared Feb 06, 2015
KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System
K143257 · KPR
Medicatech USA
Radiology · 85d
Cleared Feb 06, 2015
CAAS A-Valve
K143044 · LLZ
Pie Medical Imaging BV
Radiology · 107d
Cleared Feb 04, 2015
SIGNA Creator, SIGNA Explorer
K143251 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 84d
Cleared Feb 04, 2015
Digital Diagnostic X-ray System (GC80)
K143029 · KPR
Samsung Electronics Co., Ltd.
Radiology · 106d
Cleared Feb 04, 2015
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
K140828 · LLZ
Brainreader Aps
Radiology · 309d
Cleared Feb 03, 2015
ECHOSTAR COMFORT 1.5T MRI
K141945 · LNH
Alltech Medical Systems America, Inc.
Radiology · 201d
Cleared Jan 30, 2015
Universal Digital Interface 2W, UDI 2W
K143232 · MQB
Meridian Medical Systems, LLC
Radiology · 81d
Cleared Jan 30, 2015
EmboGuide
K142273 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 168d
Cleared Jan 29, 2015
LOGIQ P9, LOGIQ P7
K143452 · IYN
Ge Healthcare
Radiology · 58d
Cleared Jan 29, 2015
Ultimax-i
K143281 · OWB
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Jan 29, 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K142714 · IYN
Sonoscape Company Limited
Radiology · 129d