Cleared Traditional

K851812 - DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 (FDA 510(k) Clearance)

Class I Radiology device.

K851812 · Victoreen, Inc. · Radiology device
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Jun 1985
Decision
40d
Days
Class 1
Risk

K851812 is an FDA 510(k) clearance for the DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711. Classified as Test-pattern, Radiographic (product code IXF), Class I - General Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1940 - 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 Victoreen, Inc. devices

Submission Details

510(k) Number K851812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date June 05, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXF Test-pattern, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1940
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.