Cleared Traditional

K121657 - PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR

K121657 is an FDA 510(k) clearance for PROTON RADIATION THERAPY BEAM-SHAPING A..., manufactured by Proton Systems. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K121657 · Proton Systems · Radiology device
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Oct 2012
Decision
140d
Days
Class 2
Risk

K121657 is an FDA 510(k) clearance for the PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-S.... Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Proton Systems (Austin, US). The FDA issued a Cleared decision on October 23, 2012 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Proton Systems devices

FDA 510(k) Submission Details - K121657

510(k) Number K121657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2012
Decision Date October 23, 2012
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

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