Cleared Abbreviated

K103554 - METRON-CP/MD

K103554 is an FDA 510(k) clearance for METRON-CP/MD, manufactured by Eponatech, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Abbreviated 510(k) pathway after a 382-day FDA review.

K103554 · Eponatech, LLC · Radiology device
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Dec 2011
Decision
382d
Days
Class 2
Risk

K103554 is an FDA 510(k) clearance for the METRON-CP/MD. 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 Eponatech, LLC (Walnut Creek, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Moderate-to-high 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 Eponatech, LLC devices

FDA 510(k) Submission Details - K103554

510(k) Number K103554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2010
Decision Date December 20, 2011
Days to Decision 382 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 107d · This submission: 382d
Pathway characteristics
Standards-based clearance path.

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.

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