Cleared Traditional

K003882 - NUCAMMA BI90

K003882 is an FDA 510(k) clearance for NUCAMMA BI90, manufactured by Is2 Research, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K003882 · Is2 Research, Inc. · Radiology device
Download Printable Device Report (PDF)
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Feb 2001
Decision
68d
Days
Class 2
Risk

K003882 is an FDA 510(k) clearance for the NUCAMMA BI90. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Is2 Research, Inc. (Nepean, Ontario, CA). The FDA issued a Cleared decision on February 21, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Is2 Research, Inc. devices

FDA 510(k) Submission Details - K003882

510(k) Number K003882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date February 21, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 347
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K003882.
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K003849 · Ge Medical Systems, Inc. · Dec 2000
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