Cleared Traditional

K060020 - AUTOQUANT PLUS

K060020 is an FDA 510(k) clearance for AUTOQUANT PLUS, manufactured by Adac Laboratories. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K060020 · Adac Laboratories · Radiology device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
16d
Days
Class 2
Risk

K060020 is an FDA 510(k) clearance for the AUTOQUANT PLUS. 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 January 20, 2006 after a review of 16 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

FDA 510(k) Submission Details - K060020

510(k) Number K060020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2006
Decision Date January 20, 2006
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MORTEN S CHRISTENSEN

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 373
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K060020.
BIOGRAPH 64 AND BIOGRAPH 40
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CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
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