Cleared Traditional

K955643 - ALARA IMAGING SYSTEM

K955643 is an FDA 510(k) clearance for ALARA IMAGING SYSTEM, manufactured by Denoptix, Inc.. The device is a Class 2 Radiology device with product code EGY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K955643 · Denoptix, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
80d
Days
Class 2
Risk

K955643 is an FDA 510(k) clearance for the ALARA IMAGING SYSTEM. Classified as Processor, Radiographic-film, Automatic, Dental (product code EGY), Class II - Special Controls.

Submitted by Denoptix, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K955643

510(k) Number K955643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date March 01, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGY Device Classification - Class 2, Special Controls

Product Code EGY Processor, Radiographic-film, Automatic, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EGY Processor, Radiographic-film, Automatic, Dental

All 8
Devices cleared under the same product code (EGY) and FDA review panel - the closest regulatory comparables to K955643.
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
K992896 · Dental X-Ray Support Systems, Inc. · Sep 1999
SMITH S-100 TIME & TEMPERATURE CONTROL
K955825 · Smith Companies Dental Products · Apr 1996
PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
K945682 · Gendex Corp. · Feb 1995
AP201 DENTAL X-RAY FILM PROCESSOR
K900156 · Allied Photo Products Co., Inc. · May 1990
MODEL 410 DENTAL X-RAY FILM PROCESSORS
K874118 · Dent-X Co. · Nov 1987
YOSHIDA AP 100
K811211 · Kaycor Intl., Ltd. · Jun 1981
K955643 · ALARA IMAGING SYSTEM
Download PDF FDA Summary Denoptix, Inc.