Cleared Traditional

K955643 - ALARA IMAGING SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955643 · Denoptix, Inc. · Radiology device
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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.

View all Denoptix, Inc. devices

Submission Details

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
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.

Device Classification

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.