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510(k) K922165

ATC725, ATC525, AND AP300 by Gendex Corp. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
May 8, 1992
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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  • K890083 — GX-2000 STATIONARY X-RAY GENERATOR (March 31, 1989)
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  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
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  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)