Cleared Abbreviated

ORTOMED (K131348) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K131348 · Infomed Servicios Informaticos S.L. · Radiology device
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Aug 2014
Decision
452d
Days
Class 2
Risk

K131348 is an FDA 510(k) clearance for the ORTOMED. 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 Infomed Servicios Informaticos S.L. (Barcelona, ES). The FDA issued a Cleared decision on August 5, 2014 after a review of 452 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 Infomed Servicios Informaticos S.L. devices

Submission Details

510(k) Number K131348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2013
Decision Date August 05, 2014
Days to Decision 452 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
345d slower than avg
Panel avg: 107d · This submission: 452d
Pathway characteristics
Standards-based clearance path.

Device Classification

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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