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510(k) K933115

DIGITAL DISK RECORDER by Eigen — Product Code LMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1994
Date Received
June 25, 1993
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.

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  • K082341 — DSA 2000EX (August 29, 2008)
  • K081093 — 3-D IMAGING WORKSTATION (May 1, 2008)
  • K063846 — EIGEN DSA 2000 (January 26, 2007)
  • K924164 — DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT (November 23, 1992)
  • K923585 — DIGITAL FLUORO STORE (October 21, 1992)
  • K913012 — DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES (September 23, 1991)
  • K905111 — DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES (January 25, 1991)

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)