Home / 510(k) Clearances / K945682

510(k) K945682

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL by Gendex Corp. — Product Code EGY

K945682 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL". The FDA issued a decision of Substantially Equivalent on February 9, 1995. The device falls under product code EGY (Processor, Radiographic-Film, Automatic, Dental), a Class II device regulated under 21 CFR 892.1900. Gendex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1995
Date Received
November 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic, Dental
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Gendex Corp.

  • K952598 — GX-PAN PANORAMIC DENTAL X-RAY SYSTEM (June 29, 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)
  • 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)

Other clearances for product code EGY

  • K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (September 3, 1999)
  • K955825 — SMITH S-100 TIME & TEMPERATURE CONTROL (April 5, 1996)
  • K955643 — ALARA IMAGING SYSTEM (March 1, 1996)
  • K900156 — AP201 DENTAL X-RAY FILM PROCESSOR (May 14, 1990)
  • K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS (November 6, 1987)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)
  • K771433 — AUTO. DEVEL. UNIT FOO DENTAL X-RAY (August 19, 1977)
  • K770783 — FILM PROCESSOR, AUTOMATIC (May 10, 1977)

FDA data resources