Cleared Traditional

K935428 - BENNETT X-RAY DIGITAL SPOT IMAGER (FDA 510(k) Clearance)

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

K935428 · Bennett X-Ray Technologies · Radiology device
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Nov 1994
Decision
356d
Days
Class 2
Risk

K935428 is an FDA 510(k) clearance for the BENNETT X-RAY DIGITAL SPOT IMAGER. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Bennett X-Ray Technologies (Copiague, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K935428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1993
Decision Date November 01, 1994
Days to Decision 356 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
249d slower than avg
Panel avg: 107d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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.