Cleared Traditional

K932675 - GXP DENTAL X-RAY PROCESSOR
(FDA 510(k) Clearance)

K932675 · Gendex Corp. · Radiology

Jul 1993

Decision

54d

Days

Class 1

Risk

K932675 is an FDA 510(k) clearance for the GXP DENTAL X-RAY PROCESSOR. This device is classified as a Scissors, Surgical Tissue, Dental (Class I — General Controls, product code EGN).

Submitted by Gendex Corp. (Des Plaines, US). The FDA issued a Cleared decision on July 26, 1993, 54 days after receiving the submission on June 2, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K932675 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1993
Decision Date	July 26, 1993
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement