Cleared Traditional

K091928 - 10 X 10 VISION

K091928 is an FDA 510(k) clearance for 10 X 10 VISION, manufactured by Bioptics, Inc.. The device is a Class 2 Radiology device with product code MWP cleared through the Traditional 510(k) pathway after a 351-day FDA review.

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

FDA 510(k) Submission Details - K091928

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.

MWP Device Classification - Class 2, Special Controls

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.