Cleared Traditional

K244008 - Spectral CT

K244008 is the FDA 510(k) clearance for Spectral CT by Philips Medical Systems Technologies , Ltd.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K244008 · Philips Medical Systems Technologies , Ltd. · Radiology device
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May 2025
Decision
141d
Days
Class 2
Risk

K244008 is an FDA 510(k) clearance for the Spectral CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems Technologies , Ltd. (Haifa, IL). The FDA issued a Cleared decision on May 16, 2025 after a review of 141 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.

View all Philips Medical Systems Technologies , Ltd. devices

Submission Details

510(k) Number K244008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2024
Decision Date May 16, 2025
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 589
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