Cleared Traditional

K853754 - MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (FDA 510(k) Clearance)

Class I Radiology device.

K853754 · Victoreen, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
240d
Days
Class 1
Risk

K853754 is an FDA 510(k) clearance for the MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901. Classified as Instrument, Quality-assurance, Radiologic (product code LHO), Class I - General Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on May 7, 1986 after a review of 240 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Victoreen, Inc. devices

Submission Details

510(k) Number K853754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date May 07, 1986
Days to Decision 240 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 107d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHO Instrument, Quality-assurance, Radiologic
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.