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510(k) K894188

GX-ELEVATOR by Gendex Corp. — Product Code IZZ

K894188 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "GX-ELEVATOR". The FDA issued a decision of Substantially Equivalent on October 3, 1989. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Gendex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1989
Date Received
June 16, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
Device Class
Class II
Regulation Number
892.1980
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)
  • K920189 — GX-C CEPHALOMETER (April 28, 1992)
  • K890083 — GX-2000 STATIONARY X-RAY GENERATOR (March 31, 1989)
  • K873982 — GX-MOBILE X-RAY UNIT (October 30, 1987)

Other clearances for product code IZZ

  • K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (May 14, 1997)
  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K951315 — CATHETERIZATION TABLE KS-60 (May 11, 1995)
  • K951053 — ANGIOREX CAT-350B (April 6, 1995)
  • K943926 — RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (November 28, 1994)
  • K930273 — ALPHA (July 13, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100 (November 27, 1992)
  • K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (May 15, 1992)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)

FDA data resources