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510(k) K842463

GX CEPH by Gendex Corp. — Product Code EAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1984
Date Received
June 22, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type

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  • 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)

Other clearances for product code EAG

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  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K920189 — GX-C CEPHALOMETER (April 28, 1992)
  • K896099 — DIGIGRAPH DIAGNOSTIC WORK/STATION (January 31, 1991)
  • K870243 — BURNETT TMJ APPLIANCE (February 24, 1987)
  • K833006 — CEPHALOMETER & FIXATOR (January 3, 1984)
  • K810538 — PLASTICEPH (April 29, 1981)
  • K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (September 11, 1978)