Cleared Traditional

K860100 - MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902

K860100 is an FDA 510(k) clearance for MRI SLICE THICKNESS & CONTIGUITY PHANTO..., 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 102-day FDA review.

K860100 · Victoreen, Inc. · Radiology device
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Apr 1986
Decision
102d
Days
Class 1
Risk

K860100 is an FDA 510(k) clearance for the MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902. 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 April 22, 1986 after a review of 102 days - within the typical 510(k) review window.

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 - K860100

510(k) Number K860100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1986
Decision Date April 22, 1986
Days to Decision 102 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
5d faster than avg
Panel avg: 107d · This submission: 102d
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 K860100.
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
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MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
K853754 · Victoreen, Inc. · May 1986
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K860260 · Victoreen, Inc. · May 1986
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K844620 · Varian Assoc., Inc. · Jul 1985
RFA-7 RADIATION FIELD ANALYZER
K845007 · Varian Assoc., Inc. · Jul 1985