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

71 results for "Fujifilm Medical System U.S.A., Inc."
25–48 of 71
Search insights Median review: 83d Cleared: 100% Top manufacturer: Fujifilm Medical System U.S.A., Inc. Lead specialty: Radiology
Cleared Aug 30, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Apr 07, 2011
SYNAPSE 3D LIVER ANALYSIS
K110186 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 76d
Cleared Mar 04, 2011
SYNAPSE 3D CEREBRAL ANALYSIS
K103687 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 77d
Cleared Feb 08, 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · ITX
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Oct 29, 2010
FDR IMAGE STITCHING OPTION
K101686 · KPR
Fujifilm Medical System U.S.A., Inc.
Radiology · 135d
Cleared Jul 26, 2010
SYNAPSE 3D BASIC TOOLS
K101662 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 42d
Cleared Apr 14, 2010
SYNAPSE OBLIQUUS MIP/MPR/FUSION
K100881 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Aug 25, 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 28d
Cleared Aug 06, 2004
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
K041990 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Jan 09, 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 85d
Cleared Feb 10, 2000
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D...
K993861 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 87d
Cleared Jun 25, 1999
FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
K991257 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 73d
Cleared Sep 12, 1997
FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)
K972256 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Mar 31, 1997
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
K970349 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · LMD
Fujifilm Medical System U.S.A., Inc.
Radiology · 56d
Cleared Oct 28, 1996
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Mar 07, 1996
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
K960326 · LMB
Fujifilm Medical System U.S.A., Inc.
Radiology · 43d
Cleared Oct 27, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K951373 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 214d
Cleared Sep 20, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR
K952862 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared May 24, 1995
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared May 11, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K944046 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 266d