Cleared Traditional

K933035 - BCM-600TX (FDA 510(k) Clearance)

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

K933035 · B C Medical , Ltd. · Radiology device
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Oct 1993
Decision
108d
Days
Class 2
Risk

K933035 is an FDA 510(k) clearance for the BCM-600TX. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by B C Medical , Ltd. (J3y 7p9, CA). The FDA issued a Cleared decision on October 8, 1993 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1860 - 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.

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Submission Details

510(k) Number K933035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date October 08, 1993
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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.