Cleared Traditional

ALLEGRO TB, ALLEGRO N (K003434) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003434 · Adac Laboratories · Radiology device
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Nov 2000
Decision
10d
Days
Class 2
Risk

K003434 is an FDA 510(k) clearance for the ALLEGRO TB, ALLEGRO N. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on November 16, 2000 after a review of 10 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 Adac Laboratories devices

Submission Details

510(k) Number K003434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date November 16, 2000
Days to Decision 10 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 107d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 169
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K003434.
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
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ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001
E.CAM COMPUTER
K992731 · Siemens Medical Solutions USA, Inc. · Nov 1999
BEACON-P, MODEL 211059
K992335 · Philips Medical Systems (Cleveland), Inc. · Oct 1999
BEACON, MODEL 211060
K983948 · Philips Medical Systems (Cleveland), Inc. · Apr 1999