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510(k) K973413

ID. STORE (RELEASE 2.0) by I.S.G. Technologies, Inc. — Product Code LMB

K973413 is an FDA 510(k) premarket notification submitted by I.S.G. Technologies, Inc. for the device "ID. STORE (RELEASE 2.0)". The FDA issued a decision of Substantially Equivalent on November 25, 1997. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. I.S.G. Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1997
Date Received
September 9, 1997
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 I.S.G. Technologies, Inc.

  • K993673 — SNN FLUORO NAVIGATION SYSTEM (December 21, 1999)
  • K982570 — SNN SCOUT (January 13, 1999)
  • K980684 — VR NETSERVE (May 6, 1998)
  • K970865 — ISG FAMILY OF VIEWING WANDS (June 4, 1997)
  • K960714 — ISG VIEWING WAND (May 29, 1996)
  • K941933 — ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW) (July 29, 1994)
  • K911783 — ALLEGRO VIEWING WAND (April 7, 1994)
  • K901679 — RESUBMITTED ISG 3DMV WORKSTATION (May 29, 1990)
  • K872150 — I.S.G. 3DMV WORKSTATION (August 12, 1987)

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)
  • 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)
  • K964803 — UNIVISION ECHOCARDIOLOGY SYSTEM (February 11, 1997)

FDA data resources