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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10969–10992 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 14, 1996
KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
K961740 · LLZ
Kodak Health Imaging Systems, Inc.
Radiology · 195d
Cleared Nov 12, 1996
LINAC SCALPEL TREATMENT PLANNING SYSTEM
K962792 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 118d
Cleared Nov 12, 1996
QUANTEM
K963162 · KPS
Elscint, Inc.
Radiology · 90d
Cleared Nov 12, 1996
RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL
K963169 · ITX
Rapid-Aid Ltd./Ltee
Radiology · 90d
Cleared Nov 12, 1996
ORTHO 8000
K963186 · LNH
Inner Vision Mri , Ltd.
Radiology · 90d
Cleared Nov 12, 1996
RADIOGRAPHIC ITT TABLE
K963905 · KXJ
X-Ray Technologies, Inc.
Radiology · 43d
Cleared Nov 12, 1996
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964265 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 12, 1996
BIAD NUCLEAR IMAGING SYSTEM
K964266 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 12, 1996
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964267 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 12, 1996
TRIAD 88 NUCLEAR IMAGING SYSTEM
K964268 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 08, 1996
THERAPLAN PLUS
K954679 · IYE
Theratronics, Inc.
Radiology · 395d
Cleared Nov 08, 1996
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
K962364 · LMC
Codonics, Inc.
Radiology · 142d
Cleared Nov 08, 1996
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K963497 · MOT
Nordion International, Inc.
Radiology · 66d
Cleared Nov 08, 1996
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
K963617 · JAA
Shimadzu Medical Systems
Radiology · 59d
Cleared Nov 07, 1996
CASS SYSTEM (MODIFICATION)
K961484 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 223d
Cleared Nov 07, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963179 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 07, 1996
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP]...
K963592 · LMD
Dejarnette Research Systems
Radiology · 59d
Cleared Nov 07, 1996
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM...
K963594 · LMD
Dejarnette Research Systems
Radiology · 59d
Cleared Nov 07, 1996
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628 · LMD
Dejarnette Research Systems
Radiology · 57d
Cleared Nov 07, 1996
FIBRE INTERSPACED X-RAY GRID
K963893 · IXJ
Smit Rontgen
Radiology · 41d
Cleared Nov 07, 1996
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
K964263 · KGI
Lunar Corp.
Radiology · 13d
Cleared Oct 31, 1996
V-LINK 3.2 FOR WINDOWS
K963274 · IYO
Koven Technology, Inc.
Radiology · 72d
Cleared Oct 29, 1996
SONOLINE ELEGRA WITH SIESCAPE FEATURE
K961833 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 169d
Cleared Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
K962892 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 97d