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510(k) K992131

SAMSUNG RAYPAX LONG TERM ARCHIVE by Samsung Sds Co., Ltd. — Product Code LMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1999
Date Received
June 23, 1999
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 Samsung Sds Co., Ltd.

  • K002062 — SAMSUNG 10DR IMPLANT SYSTEM (November 9, 2000)
  • K992426 — RAYPAX WEB CLINICAL SYSTEM (October 13, 1999)
  • K992306 — SAMSUNG RAYPAX DISPLAY WORKSTATION (September 22, 1999)
  • K992112 — SAMSUNG RAYPAX FILM DIGITIZER (September 9, 1999)
  • K991537 — SAMSUNG RAYPAX SYSTEM (July 6, 1999)

Other clearances for product code LMB

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