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510(k) K960326

FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM by Fujifilm Medical System U.S.A., Inc. — Product Code LMB

K960326 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 1996. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1996
Date Received
January 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Digital Image Storage, Radiological
Device Class
Class I
Regulation Number
892.2010
Review Panel
RA
Submission Type

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

Other clearances by Fujifilm Medical System U.S.A., Inc.

  • K163675 — Processor VP-7000, Light Source BL-7000 (April 25, 2017)
  • K153206 — Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (March 3, 2016)
  • K151474 — Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (February 18, 2016)
  • K152138 — FDR D-EVO GL Flat Panel Detector System (November 5, 2015)
  • K150221 — EPX-4440HD and EPX-4400HD with FICE (October 1, 2015)
  • K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (May 14, 2015)
  • K142003 — FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (October 21, 2014)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132188 — MAMMOGRAPHY VIEWER SMV658 (October 25, 2013)
  • K130542 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (June 14, 2013)

Other clearances for product code LMB

  • K992131 — SAMSUNG RAYPAX LONG TERM ARCHIVE (September 13, 1999)
  • K984405 — ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (February 8, 1999)
  • K983447 — WISE (II) IMAGE MANAGEMENT SYSTEM (October 29, 1998)
  • K980243 — PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (April 3, 1998)
  • K973463 — OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (December 2, 1997)
  • K973413 — ID. STORE (RELEASE 2.0) (November 25, 1997)
  • K972380 — KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (September 11, 1997)
  • K971848 — TDK MEDICAL GRADE CD-R (August 15, 1997)
  • K971451 — WISE IMAGE MANAGEMENT SYSTEM (June 26, 1997)
  • K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)

FDA data resources