Cleared Traditional

K130278 - MR PERMEABILITY

K130278 is the FDA 510(k) clearance for MR PERMEABILITY by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K130278 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
113d
Days
Class 2
Risk

K130278 is an FDA 510(k) clearance for the MR PERMEABILITY. 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 Philips Medical Systems Nederland B.V. (Cleveland, US). The FDA issued a Cleared decision on May 29, 2013 after a review of 113 days - within the typical 510(k) review window.

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 Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K130278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date May 29, 2013
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 107d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K130278.
ESIE APPS SUITE
K132062 · Siemens Medical Solutions USA, Inc. · Jul 2013
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
K130724 · Straumann USA · Jun 2013
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K130542 · Fujifilm Medical System U.S.A., Inc. · Jun 2013
NIO COLOR 3MP LED
K131295 · Barco N.V. · May 2013
CORONIS 3MP
K131246 · Barco N.V. · May 2013
4D VIEW
K131118 · Ge Healthcare · May 2013