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510(k) K964806

MD-1835 by Fischer Imaging Corp. — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1997
Date Received
November 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type

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  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K945619 — ATHENA HFX (March 23, 1995)
  • K944150 — MICRO X-65 HF (September 16, 1994)
  • K944148 — MICRO X-30HF (September 16, 1994)

Other clearances for product code IXL

  • K111304 — OPTIMA XR120 (July 19, 2011)
  • K950317 — ADVANTX 1824 SPOTFILM DEVICE (February 8, 1995)
  • K940386 — KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP (August 17, 1994)
  • K942367 — AXT 1400 SPOTFILM DEVICE (June 6, 1994)
  • K924593 — DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (November 24, 1992)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K902146 — SFD-035 SPOT FILM DEVICE (May 31, 1990)
  • K882492 — A.X.T. SPOTFILM DEVICE (July 21, 1988)
  • K881589 — 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (July 18, 1988)
  • K842184 — SPOT-FILM DEVICE 8835 (July 17, 1984)