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510(k) K850117

XMA 325 (X-RAY GENERATOR) by Summit Industries, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
January 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

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  • K850198 — FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG (May 14, 1985)
  • K850118 — XMA INTEGRATED TABLE (April 9, 1985)

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  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)