Cleared Traditional

K982010 - FACTS

K982010 is the FDA 510(k) clearance for FACTS by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K982010 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Nov 1998
Decision
164d
Days
Class 2
Risk

K982010 is an FDA 510(k) clearance for the FACTS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on November 19, 1998 after a review of 164 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 (Cleveland), Inc. devices

Submission Details

510(k) Number K982010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date November 19, 1998
Days to Decision 164 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
57d slower than avg
Panel avg: 107d · This submission: 164d
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.

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

All 586
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K982010.
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