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510(k) K925094

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS by Gendex Corp. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1993
Date Received
October 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Gendex Corp.

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  • K935046 — GX-770 X-RAY CONTROL, MODEL 46-404600G4 (February 18, 1994)
  • K931001 — ORALIX DC (September 14, 1993)
  • K932675 — GXP DENTAL X-RAY PROCESSOR (July 26, 1993)
  • K922165 — ATC725, ATC525, AND AP300 (July 27, 1992)
  • K920189 — GX-C CEPHALOMETER (April 28, 1992)
  • K894188 — GX-ELEVATOR (October 3, 1989)
  • K890083 — GX-2000 STATIONARY X-RAY GENERATOR (March 31, 1989)
  • K873982 — GX-MOBILE X-RAY UNIT (October 30, 1987)

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