Cleared Traditional

K921381 - MEDGRAPHIX INTL VR 1000 SERIES (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921381 · Medgraphix Intl. · Radiology device
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Nov 1992
Decision
224d
Days
Class 2
Risk

K921381 is an FDA 510(k) clearance for the MEDGRAPHIX INTL VR 1000 SERIES. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Medgraphix Intl. (Rosemont, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 224 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 Medgraphix Intl. devices

Submission Details

510(k) Number K921381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date November 02, 1992
Days to Decision 224 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 107d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.