FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
10513–10536 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 26, 1997
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K964969 · MOS
GE Medical Systems
Radiology · 196d
Cleared Jun 26, 1997
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
K971167 · IZD
Neoprobe Corp.
Radiology · 87d
Cleared Jun 26, 1997
IDS4 IMAGE DISPLAY SYSTEM SERIES
K971368 · LLZ
O Tech, Inc.
Radiology · 73d
Cleared Jun 26, 1997
WISE IMAGE MANAGEMENT SYSTEM
K971451 · LMB
O Tech, Inc.
Radiology · 66d
Cleared Jun 26, 1997
TV MONITOR (P12/17)
K972136 · IZI
Perkins Mfg. Co.
Radiology · 20d
Cleared Jun 25, 1997
SPLITSCREEN (ME-975)
K971153 · LMD
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 25, 1997
MULTIPICS(ME-977)
K971154 · LMD
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Jun 20, 1997
NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2
K964206 · IYE
Nucletron Corp.
Radiology · 242d
Cleared Jun 20, 1997
PHOTON RADIOSURGERY SYSTEM (PRS)
K964947 · JAD
Photoelectron Corporation
Radiology · 192d
Cleared Jun 20, 1997
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH...
K970049 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 165d
Cleared Jun 20, 1997
GENERAL PURPOSE TRANDUCER COVER
K970513 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT...
K970514 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
GENERAL PURPOSE LATEX TRANSDUCER COVERS
K970515 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
GLORY
K970680 · IZH
Elscint, Inc.
Radiology · 116d
Cleared Jun 20, 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jun 20, 1997
LEO 7000 QUADRATURE KNEE COIL
K971246 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Jun 20, 1997
STRATASYS FDM MEDMODELER SYSTEM
K971290 · LLZ
Paladin Medical, Inc.
Radiology · 74d
Cleared Jun 20, 1997
NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO
K971714 · LLZ
National Data Corp.
Radiology · 42d
Cleared Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO....
K965044 · LNH
Elscint, Inc.
Radiology · 185d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · KGI
Hologic, Inc.
Radiology · 400d
Cleared Jun 13, 1997
MITAYA ALUMINUM INTERSPACED X-RAY GRID
K964025 · IXJ
X-Ray Accessory Corp.
Radiology · 249d
Cleared Jun 13, 1997
VERIDOSE DIODES
K964785 · IYE
Victoreen, Inc.
Radiology · 196d
Cleared Jun 13, 1997
MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
K970964 · LLZ
International Imaging Electronics
Radiology · 88d
Cleared Jun 13, 1997
CARDIOMATCH
K970970 · KPS
Focus Medical SA
Radiology · 88d