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510(k) K901956

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) by Eigen — Product Code LMB

K901956 is an FDA 510(k) premarket notification submitted by Eigen for the device "DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)". The FDA issued a decision of Substantially Equivalent on July 2, 1990. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. Eigen has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1990
Date Received
May 1, 1990
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 Eigen

  • K222222 — Artemis, Artemis TPO, Artemis MX (October 12, 2023)
  • K173744 — ProFuse CAD (November 21, 2018)
  • K162474 — Artemis (October 21, 2016)
  • K082341 — DSA 2000EX (August 29, 2008)
  • K081093 — 3-D IMAGING WORKSTATION (May 1, 2008)
  • K063846 — EIGEN DSA 2000 (January 26, 2007)
  • K933115 — DIGITAL DISK RECORDER (April 7, 1994)
  • 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)

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