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
6913–6936 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 21, 2008
16CH AI BREAST COILS 1.5 T AND 3 T
K083255 · MOS
Rapid Biomedical GmbH
Radiology · 17d
Cleared Nov 20, 2008
SNTRYPACS
K082240 · LLZ
Qstar Technologies, Inc.
Radiology · 105d
Cleared Nov 20, 2008
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
K082628 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 72d
Cleared Nov 20, 2008
INFINITT XELIS
K082990 · LLZ
Infinitt Co., Ltd.
Radiology · 44d
Cleared Nov 19, 2008
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
K082773 · IYE
Standard Imaging, Inc.
Radiology · 58d
Cleared Nov 18, 2008
DIGITAL RADIOGRAPHY, FLEXDR C30
K082347 · MQB
Konica Minolta Technoproduct Co., Ltd.
Radiology · 95d
Cleared Nov 18, 2008
STEREO NAVIGATOR ACCESSORY, STN-1000
K082354 · KPS
Naviscan Pet Systems
Radiology · 95d
Cleared Nov 18, 2008
IC-PRO SYSTEM, VERSION 3.1.0.4
K082907 · IZI
Paieon, Inc.
Radiology · 49d
Cleared Nov 18, 2008
VIDA PULMONARY WORKSTATION 2 (PW2)
K083227 · JAK
Vida Diagnostics, Inc.
Radiology · 15d
Cleared Nov 14, 2008
SYNGO IMAGING XS
K082430 · LLZ
Siemens AG Medical Solutions
Radiology · 84d
Cleared Nov 14, 2008
C-QUEST
K082581 · KPS
Medx, Inc.
Radiology · 70d
Cleared Nov 14, 2008
CENTRICITY PACS WEB DIAGNOSTIC
K083018 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 36d
Cleared Nov 13, 2008
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K082142 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 106d
Cleared Nov 13, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K083035 · NZT
Sicel Technologies, Inc.
Radiology · 30d
Cleared Nov 10, 2008
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
K082606 · MUJ
D3 Radiation Planning
Radiology · 63d
Cleared Nov 07, 2008
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
K082243 · OWB
General Medical Merate S.P.A
Radiology · 92d
Cleared Nov 07, 2008
SYNGO MR B17
K082427 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Nov 07, 2008
MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL
K082627 · IZL
Minxray, Inc.
Radiology · 59d
Cleared Nov 07, 2008
ONCENTRA RT VIEWER 1.0
K082642 · MUJ
Nucletron Corporation
Radiology · 57d
Cleared Nov 07, 2008
1.5T ATLAS SPEEDER HEAD-NECK COIL
K083160 · MOS
Quality Electrodynamics
Radiology · 11d
Cleared Nov 06, 2008
MYRAY SKYVIEW
K081088 · MUH
Cefla S.C.
Radiology · 204d
Cleared Nov 06, 2008
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K082261 · KPR
Dxrad Solutions , Ltd.
Radiology · 90d
Cleared Nov 06, 2008
INFINITT CARDIOLOGY PACS
K082706 · LLZ
Infinitt Co., Ltd.
Radiology · 51d
Cleared Nov 06, 2008
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
K082987 · MOS
Invivo
Radiology · 30d