PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL— 510(k) K945682

Name: FDA 510(k) clearance K945682
Creator: U.S. Food and Drug Administration
Published: 1995-02-09

Substantially Equivalent

Gendex Corp.

FDA 510(k) clearance K945682 for PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL, Substantially Equivalent on 1995-02-09. Applicant: Gendex Corp.. Device class: 2.

Clearance details

Applicant: Gendex Corp.
Product code: Code EGY
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1994-11-21
Decision date: 1995-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EGY

view all

K992896 — DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)1999-09-03
K955825 — SMITH S-100 TIME & TEMPERATURE CONTROL1996-04-05
K955643 — ALARA IMAGING SYSTEM1996-03-01
K900156 — AP201 DENTAL X-RAY FILM PROCESSOR1990-05-14
K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS1987-11-06

More clearances from Gendex Corp.

view all

K952598 — GX-PAN PANORAMIC DENTAL X-RAY SYSTEM1995-06-29
K935046 — GX-770 X-RAY CONTROL, MODEL 46-404600G41994-02-18
K925094 — VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS1993-09-29
K931001 — ORALIX DC1993-09-14
K932675 — GXP DENTAL X-RAY PROCESSOR1993-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.