Cleared Traditional

K853754 - MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901

K853754 is an FDA 510(k) clearance for MAGNETIC RESONANCE IMAGING UNIFORMITY/T..., manufactured by Victoreen, Inc.. The device is a Class 1 Radiology device with product code LHO cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K853754 · Victoreen, Inc. · Radiology device
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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

FDA 510(k) Submission Details - K853754

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 107d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

LHO Device Classification - Class 1, General Controls

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.

Regulatory Peers - LHO Instrument, Quality-assurance, Radiologic

Devices cleared under the same product code (LHO) and FDA review panel - the closest regulatory comparables to K853754.
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