Cleared Abbreviated

K131348 - ORTOMED (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2262
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K131348.
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · Broncus Medical, Inc. · Apr 2026
CCI PACS VIEWER (PACS-US-001)
K254237 · CliniComp, Intl. · Apr 2026
ARTICOR planner
K252195 · Artiness S.R.L · Mar 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · Boston Scientific Corporation · Mar 2026
Aeka Imaging
K253111 · Good Methods Global, Inc. · Mar 2026
Mimics Thoracic Planner
K251964 · Materialise NV · Mar 2026