Cleared Traditional

K212875 - Spectral CT on Rails

K212875 is an FDA 510(k) clearance for Spectral CT on Rails, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K212875 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
246d
Days
Class 2
Risk

K212875 is an FDA 510(k) clearance for the Spectral CT on Rails. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on May 13, 2022 after a review of 246 days - an extended review cycle.

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 Nederland B.V. devices

FDA 510(k) Submission Details - K212875

510(k) Number K212875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2021
Decision Date May 13, 2022
Days to Decision 246 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
139d slower than avg
Panel avg: 107d · This submission: 246d
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 721
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