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510(k) K952188

ADVIEWER 2000 by Adp , Ltd. — Product Code IXC

K952188 is an FDA 510(k) premarket notification submitted by Adp , Ltd. for the device "ADVIEWER 2000". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
May 9, 1995
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 for product code IXC

  • K991302 — SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS (June 1, 1999)
  • K973965 — SMART MOTORIZED VIEWER (December 12, 1997)
  • K973115 — ARRIPRO 35 ST/TV (September 2, 1997)
  • K970240 — DIFFUSER PANEL (March 11, 1997)
  • K954998 — LILY DARK VIEWER (January 29, 1996)
  • K954199 — VOXBOX (September 29, 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)

FDA data resources