Cleared Traditional

K150665 - Philips Spectral CT Applications

K150665 is an FDA 510(k) clearance for Philips Spectral CT Applications, manufactured by Philips Medical Systems Nethrlands BV. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K150665 · Philips Medical Systems Nethrlands BV · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
144d
Days
Class 2
Risk

K150665 is an FDA 510(k) clearance for the Philips Spectral CT Applications. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems Nethrlands BV (Best Noord-Brabant, NL). The FDA issued a Cleared decision on August 7, 2015 after a review of 144 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K150665

510(k) Number K150665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2015
Decision Date August 07, 2015
Days to Decision 144 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
37d slower than avg
Panel avg: 107d · This submission: 144d
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 Consultant

Philips Medical Systems (Cleveland), Inc.
SUSAN QUICK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 780
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K150665.
Respiratory Gating for Scanners
K151533 · Varian Medical Systems, Inc. · Aug 2015
syngo.CT Single Source Dual Energy
K150745 · Siemens Medical Solutions USA, Inc. · Aug 2015
syngo.CT Dual Energy
K150757 · Siemens Medical Solutions USA, Inc. · Aug 2015
syngo.CT Dental
K150785 · Siemens Medical Solutions USA, Inc. · May 2015
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
K143294 · Toshibamedical Systems Corporation · May 2015
Vitrea CT Myocardial Perfusion
K150104 · Vital Images, Inc. · Apr 2015