Cleared Traditional

K133674 - PHILIPS IQON SPECTRAL CT

K133674 is an FDA 510(k) clearance for PHILIPS IQON SPECTRAL CT, manufactured by Philips Healthcare (Cleveland). The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K133674 · Philips Healthcare (Cleveland) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
357d
Days
Class 2
Risk

K133674 is an FDA 510(k) clearance for the PHILIPS IQON SPECTRAL CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Healthcare (Cleveland) (Cleveland, US). The FDA issued a Cleared decision on November 21, 2014 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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. Elevated predicate reliance profile. 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 Healthcare (Cleveland) devices

FDA 510(k) Submission Details - K133674

510(k) Number K133674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date November 21, 2014
Days to Decision 357 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
250d slower than avg
Panel avg: 107d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 640
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K133674.
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
K143223 · Toshibamedical Systems Corporation · Jan 2015
CLEARVIEW
K133373 · Neusoft Medical Systems Co., Ltd. · Dec 2014
AQUILION PRIME, V6.00
K141741 · Toshibamedical Systems Corporation · Nov 2014
SYNGO, CT LIVER ANALYSIS
K133643 · Siemens Medi Cal Solutions, Inc. · Nov 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677 · Siemens Medical Solutions USA, Inc. · Oct 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · Philips Medical Systems · Sep 2014