Cleared Traditional

K022899 - PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0

K022899 is an FDA 510(k) clearance for PHILIPS INTEGRIS ALLURA FLAT DETECTOR R..., manufactured by Philips Medical Systems North America Co.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K022899 · Philips Medical Systems North America Co. · Radiology device
Download Printable Device Report (PDF)
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Nov 2002
Decision
80d
Days
Class 2
Risk

K022899 is an FDA 510(k) clearance for the PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems North America Co. devices

FDA 510(k) Submission Details - K022899

510(k) Number K022899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date November 22, 2002
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 194
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