Cleared Traditional

K896151 - EMISSION TOMOGRAPHY CAROUSEL (FDA 510(k) Clearance)

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

K896151 · Atf Consolidated · Radiology device
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Apr 1991
Decision
539d
Days
Class 2
Risk

K896151 is an FDA 510(k) clearance for the EMISSION TOMOGRAPHY CAROUSEL. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Atf Consolidated (Deer Park, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Atf Consolidated devices

Submission Details

510(k) Number K896151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date April 16, 1991
Days to Decision 539 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
432d slower than avg
Panel avg: 107d · This submission: 539d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 469
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