Cleared Traditional

K161395 - SPEC Model M13 (FDA 510(k) Clearance)

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

K161395 · Source Production and Equipment Co., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
48d
Days
Class 2
Risk

K161395 is an FDA 510(k) clearance for the SPEC Model M13. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Source Production and Equipment Co., Inc. (Saint Rose, US). The FDA issued a Cleared decision on July 6, 2016 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Source Production and Equipment Co., Inc. devices

Submission Details

510(k) Number K161395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2016
Decision Date July 06, 2016
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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.