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510(k) K843349

ND3100 VIDEO IMAGER by Nuclear Data, Inc. — Product Code LMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
August 27, 1984
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 Nuclear Data, Inc.

  • K891466 — ACCUSPEC THYROID UPTAKE SYSTEM (June 6, 1989)
  • K881383 — ND1100 BONE DENSITY SCANNER (May 22, 1989)
  • K844835 — ND2100 SPINE SCANNER (April 18, 1985)
  • K844766 — ND1100 BONE DENSITY SCANNER (April 16, 1985)
  • K841440 — ND62T THYROID UPTAKE SYSTEM (June 5, 1984)
  • K841352 — ND1200 RIA COUNTER (May 2, 1984)

Other clearances for product code LMB

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  • 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)