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
7609–7632 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 22, 2006
MODIFICATION TO SYNGO INSPACE 4D
K062673 · JAK
Siemens AG Medical Solutions
Radiology · 14d
Cleared Sep 21, 2006
MODIFICATION TO HEXAPOD RT COUCH TOP
K062639 · JAI
Medical Intelligence...
Radiology · 15d
Cleared Sep 21, 2006
EP NAVIGATOR SOFTWARE
K062650 · LLZ
Philips Medical Systems
Radiology · 14d
Cleared Sep 20, 2006
LEICA MODEL FL800
K061871 · IZI
Leica Microsystems, Inc.
Radiology · 79d
Cleared Sep 20, 2006
IGUIDE SYSTEM
K062611 · IYE
Medical Intelligence...
Radiology · 15d
Cleared Sep 19, 2006
IQ-SYSTEM PACS SYSTEM
K062488 · LLZ
Image Information Systems, Ltd.
Radiology · 25d
Cleared Sep 18, 2006
GENTLE COLON (REVISION 2.0)
K061532 · LLZ
Rendoscopy, Inc.
Radiology · 108d
Cleared Sep 18, 2006
CONNECT IMAGING PACS
K061972 · LLZ
Connect Imaging, Inc.
Radiology · 67d
Cleared Sep 18, 2006
CRYSTALVIEW R200
K062390 · MQB
Alara, Inc.
Radiology · 33d
Cleared Sep 18, 2006
DIGI-LITE TCD DEVICE
K062578 · IYN
Rimed , Ltd.
Radiology · 18d
Cleared Sep 15, 2006
PULSERA
K061685 · IZL
Philips Medical Systems North America...
Radiology · 92d
Cleared Sep 15, 2006
XPLORER 1100
K062417 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Sep 14, 2006
SEDECAL X PLUS LP PLUS
K062335 · KPR
Sedecal., Sa.
Radiology · 35d
Cleared Sep 13, 2006
MAMMOPAD RADIOLUCENT CUSHION
K062141 · IYX
Biolucent, Inc.
Radiology · 48d
Cleared Sep 13, 2006
XPLORER 1590
K062405 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 29d
Cleared Sep 11, 2006
BIOPSY DIGIT-AM
K062039 · IZH
Giotto USA, LLC
Radiology · 54d
Cleared Sep 11, 2006
VOYAGER PACS SYSTEM
K062062 · LLZ
Voyager Imaging
Radiology · 53d
Cleared Sep 11, 2006
CTC WORKSTATION, MODEL 2200
K062229 · LLZ
Medical Diagnostic Technologies, Inc.
Radiology · 40d
Cleared Sep 08, 2006
SUPERDIMENSION/BRONCHUS PREMIUM 2
K062315 · JAK
Superdimension, Ltd.
Radiology · 30d
Cleared Sep 06, 2006
ART LAB SOFTWARE
K061961 · LLZ
Pie Medical
Radiology · 57d
Cleared Sep 06, 2006
XCELERA
K061995 · LLZ
Philips Medical Systems North America...
Radiology · 54d
Cleared Sep 06, 2006
AIE REGION OF INTEREST IMAGE ENHANCEMENT
K062059 · LLZ
Advanced Image Enhancement
Radiology · 48d
Cleared Sep 05, 2006
CORONIS 3MP AND MDCG 3120-CB
K061924 · LLZ
Barcoview
Radiology · 60d
Cleared Sep 05, 2006
CORONIS COLOR 3MP AND MDCC 3120-DL
K061927 · LLZ
Barcoview
Radiology · 60d