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 ×
15,589 results
6289–6312 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 01, 2010
LLX240AB01
K102587 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 83d
Cleared Nov 29, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR
K101590 · MQB
VATECH Co., Ltd.
Radiology · 175d
Cleared Nov 24, 2010
AERODR SYSTEM
K102349 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 97d
Cleared Nov 23, 2010
ACCULMAING
K102849 · LLZ
Radiology Information Systems, Inc.
Radiology · 55d
Cleared Nov 23, 2010
PVS MODEL 1.0
K102237 · IYE
Medcom GmbH
Radiology · 106d
Cleared Nov 19, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K102390 · IYN
Sonosite,Inc.
Radiology · 88d
Cleared Nov 19, 2010
PENRITH ELETTRA ULTRASOUND SYSTEM
K100598 · IYN
Penrith Corporation
Radiology · 261d
Cleared Nov 19, 2010
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
K092728 · LLZ
Totoku Electric Co., Ltd.
Radiology · 441d
Cleared Nov 18, 2010
WIRELESS DR IMAGING OPTION-WDR1
K102615 · MQB
Ge Medical Systems, LLC
Radiology · 70d
Cleared Nov 18, 2010
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
K093891 · JAK
Toshibamedical Systems Corporation
Radiology · 335d
Cleared Nov 17, 2010
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K102650 · IYE
Accuray Incorporated
Radiology · 64d
Cleared Nov 15, 2010
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
K103215 · JAQ
Cianna Medical
Radiology · 14d
Cleared Nov 10, 2010
IMPROVIS IMAGING SYSTEM
K101654 · LLZ
American Dental Partners, Inc.
Radiology · 152d
Cleared Nov 09, 2010
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
K102344 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 83d
Cleared Nov 05, 2010
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM
K102393 · IYO
Ge Medical System Israel , Ltd.
Radiology · 74d
Cleared Nov 05, 2010
COMPACT TOUCH STS
K102198 · IYO
Quantel Medical S.A.
Radiology · 93d
Cleared Nov 05, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K101220 · MUJ
American Radiosurgery, Inc.
Radiology · 186d
Cleared Nov 04, 2010
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
K102388 · IYN
Ge Medical System Israel , Ltd.
Radiology · 73d
Cleared Nov 04, 2010
INTEGRITY MODEL 1014284
K102200 · IYE
Elekta , Ltd.
Radiology · 92d
Cleared Nov 03, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K102865 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 34d
Cleared Nov 03, 2010
DISCOVERY NM 750B
K102231 · IYX
Ge Medical Systems Israel, Functional...
Radiology · 86d
Cleared Nov 02, 2010
MUCHECK, VERSION 9.0
K102583 · IYE
Oncology Data Systems, Inc.
Radiology · 55d
Cleared Oct 29, 2010
DX-D 300
K103050 · KPR
Agfa Healthcare N.V.
Radiology · 14d
Cleared Oct 29, 2010
FULACCESS MODEL 1.0
K101707 · LLZ
Fulcrum Medical, Inc.
Radiology · 134d