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510(k) K920189

GX-C CEPHALOMETER by Gendex Corp. — Product Code EAG

K920189 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "GX-C CEPHALOMETER". The FDA issued a decision of Substantially Equivalent on April 28, 1992. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. Gendex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1992
Date Received
January 15, 1992
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

Other clearances by Gendex Corp.

  • K952598 — GX-PAN PANORAMIC DENTAL X-RAY SYSTEM (June 29, 1995)
  • K945682 — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (February 9, 1995)
  • K935046 — GX-770 X-RAY CONTROL, MODEL 46-404600G4 (February 18, 1994)
  • 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)
  • 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)

Other clearances for product code EAG

  • K030699 — VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (May 29, 2003)
  • K021372 — VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (June 7, 2002)
  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K896099 — DIGIGRAPH DIAGNOSTIC WORK/STATION (January 31, 1991)
  • K870243 — BURNETT TMJ APPLIANCE (February 24, 1987)
  • K842463 — GX CEPH (August 2, 1984)
  • K833006 — CEPHALOMETER & FIXATOR (January 3, 1984)
  • K810538 — PLASTICEPH (April 29, 1981)
  • K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (September 11, 1978)

FDA data resources