Cleared Traditional

K840131 - COMPUTED TOMOGRAPHY CALIBRATION PHANT (FDA 510(k) Clearance)

Class I Radiology device.

K840131 · Imatron, Inc. · Radiology device
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Feb 1984
Decision
42d
Days
Class 1
Risk

K840131 is an FDA 510(k) clearance for the COMPUTED TOMOGRAPHY CALIBRATION PHANT. Classified as Phantom, Anthropomorphic, Radiographic (product code IXG), Class I - General Controls.

Submitted by Imatron, Inc. (Walker, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1950 - 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 Imatron, Inc. devices

Submission Details

510(k) Number K840131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date February 21, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXG Phantom, Anthropomorphic, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.