Cleared Traditional

K151435 - MRCAT

K151435 is the FDA 510(k) clearance for MRCAT by Philips Medical Systems MR Finland. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K151435 · Philips Medical Systems MR Finland · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
273d
Days
Class 2
Risk

K151435 is an FDA 510(k) clearance for the MRCAT. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Philips Medical Systems MR Finland (Vantaa, FI). The FDA issued a Cleared decision on February 25, 2016 after a review of 273 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems MR Finland devices

Submission Details

510(k) Number K151435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date February 25, 2016
Days to Decision 273 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 107d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - MUJ System, Planning, Radiation Therapy Treatment

All 131
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K151435.
Eclipse Treatment Planning System
K170969 · Varian Medical Systems, Inc. · Jul 2017
Pinnacle Radiation Therapy Planning System
K170086 · Philips Medical Systems (Cleveland), Inc. · Feb 2017
syngo.via RT Image Suite
K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
Eclipse Treatment Planning System
K152393 · Varian Medical Systems, Inc. · Sep 2015
syngo VSim
K151887 · Siemens Medical Solutions USA, Inc. · Sep 2015
Leksell GammaPlan
K151666 · Elekta Instrument AB · Sep 2015