Cleared Traditional

K091928 - 10 X 10 VISION (FDA 510(k) Clearance)

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

K091928 · Bioptics, Inc. · Radiology device
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Jun 2010
Decision
351d
Days
Class 2
Risk

K091928 is an FDA 510(k) clearance for the 10 X 10 VISION. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Bioptics, Inc. (Tucson, US). The FDA issued a Cleared decision on June 16, 2010 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

View all Bioptics, Inc. devices

Submission Details

510(k) Number K091928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date June 16, 2010
Days to Decision 351 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
244d slower than avg
Panel avg: 107d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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.