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510(k) K873982

GX-MOBILE X-RAY UNIT by Gendex Corp. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1987
Date Received
September 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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  • K925094 — VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS (September 29, 1993)
  • 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)

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