Cleared Traditional

K151435 - MRCAT

K151435 is an FDA 510(k) clearance for MRCAT, manufactured by Philips Medical Systems MR Finland. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K151435

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
Combination Product No
PCCP Authorized No
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.

MUJ Device Classification - Class 2, Special Controls

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 212
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K151435.
syngo.via RT Image Suite
K162370 · Siemens Medical Solutions USA, Inc. · Oct 2016
Precision Treatment Planning System
K161136 · Accuray Incorporated · Jun 2016
RayStation
K160093 · RaySearch Laboratories AB (PUBL) · Apr 2016
Radiance V3
K153368 · Gmv Soluciones Globales Internet S.A.U. · Feb 2016
Panther StereoSeed
K143514 · Prowess, Inc. · Dec 2015
CORVUS Radiation Therapy Planning System
K151469 · Best Nomos · Nov 2015