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510(k) K973965

SMART MOTORIZED VIEWER by Smartlight, Ltd. — Product Code IXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1997
Date Received
October 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Radiographic-Film
Device Class
Class I
Regulation Number
892.1890
Review Panel
RA
Submission Type

Other clearances by Smartlight, Ltd.

  • K991302 — SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS (June 1, 1999)

Other clearances for product code IXC

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  • K970240 — DIFFUSER PANEL (March 11, 1997)
  • K954998 — LILY DARK VIEWER (January 29, 1996)
  • K954199 — VOXBOX (September 29, 1995)
  • K952188 — ADVIEWER 2000 (May 30, 1995)
  • K922848 — ULTRALITE X-RAY FILM ILLUMINATOR (September 28, 1992)
  • K922079 — ROTOLUX, SELECTOLUX, SHUTTERVUE (June 16, 1992)
  • K883702 — EXCELVIEW ILLUMINATOR (September 19, 1988)
  • K875233 — VARIVIEWER (X-RAY FILM VIEWER) (January 19, 1988)