ALARA IMAGING SYSTEM— 510(k) K955643

Substantially Equivalent

Denoptix, Inc.

FDA 510(k) clearance K955643 for ALARA IMAGING SYSTEM, Substantially Equivalent on 1996-03-01. Applicant: Denoptix, Inc.. Device class: 2.

Clearance details

Applicant: Denoptix, Inc.
Product code: Code EGY
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1995-12-12
Decision date: 1996-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EGY

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
K945682 — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL1995-02-09
K900156 — AP201 DENTAL X-RAY FILM PROCESSOR1990-05-14
K874118 — MODEL 410 DENTAL X-RAY FILM PROCESSORS1987-11-06

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