Cleared Traditional

K132236 - .DECIMAL PROTON APERTURE

K132236 is an FDA 510(k) clearance for .DECIMAL PROTON APERTURE, manufactured by .Decimal, Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K132236 · .Decimal, Inc. · Radiology device
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Oct 2013
Decision
90d
Days
Class 2
Risk

K132236 is an FDA 510(k) clearance for the .DECIMAL PROTON APERTURE. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on October 16, 2013 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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 .Decimal, Inc. devices

FDA 510(k) Submission Details - K132236

510(k) Number K132236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2013
Decision Date October 16, 2013
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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.

Regulatory Peers - IXI Block, Beam-shaping, Radiation Therapy

All 16
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