Cleared Traditional

K003434 - ALLEGRO TB

K003434 is the FDA 510(k) clearance for ALLEGRO TB by Adac Laboratories. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Rheinland of North America, Inc.
DAVID KOLESAR

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K003434.
GE VISION NUCLEAR MEDICINE WORKSTATION
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ORBITER II CCI/SPECT ORBITER II CCI/SPECT
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GE ADVANCE NXI PET SYSTEM
K003849 · Ge Medical Systems, Inc. · Dec 2000
SKYLIGHT IMAGING SYSTEM
K000908 · Adac Laboratories · Apr 2000
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
K992992 · Toshiba America Medical Systems, In.C · Dec 1999
E.CAM COMPUTER
K992731 · Siemens Medical Solutions USA, Inc. · Nov 1999