Cleared Traditional

K942883 - DIGITAL I.D. CAMERA (FDA 510(k) Clearance)

Class I Radiology device.

K942883 · Miles Inc., Agfa Division · Radiology device
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Sep 1994
Decision
105d
Days
Class 1
Risk

K942883 is an FDA 510(k) clearance for the DIGITAL I.D. CAMERA. Classified as System, X-ray, Film Marking, Radiographic (product code JAC), Class I - General Controls.

Submitted by Miles Inc., Agfa Division (Ridgefield Park, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Inc., Agfa Division devices

Submission Details

510(k) Number K942883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1994
Decision Date September 30, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAC System, X-ray, Film Marking, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.