Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

72 results for "Fujifilm Medical System U.S.A., Inc."
25–48 of 72
Search insights Median review: 83d Cleared: 100% Top manufacturer: Fujifilm Medical System U.S.A., Inc. Lead specialty: Radiology
Cleared Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 92d
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