Cleared Traditional

K132586 - PAXERAPACS

K132586 is an FDA 510(k) clearance for PAXERAPACS, manufactured by Paxeramed. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K132586 · Paxeramed · Radiology device
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Oct 2013
Decision
76d
Days
Class 2
Risk

K132586 is an FDA 510(k) clearance for the PAXERAPACS. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Paxeramed (Aubrey, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Paxeramed devices

FDA 510(k) Submission Details - K132586

510(k) Number K132586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2013
Decision Date October 31, 2013
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1238
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