Cleared Traditional

K922303 - M-LINK

K922303 is an FDA 510(k) clearance for M-LINK, manufactured by Medimage, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K922303 · Medimage, Inc. · Radiology device
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Dec 1992
Decision
210d
Days
Class 2
Risk

K922303 is an FDA 510(k) clearance for the M-LINK. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Medimage, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on December 11, 1992 after a review of 210 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Medimage, Inc. devices

FDA 510(k) Submission Details - K922303

510(k) Number K922303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date December 11, 1992
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 391
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K922303.
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
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K924877 · Adac Laboratories · Dec 1992
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K923309 · GE Medical Systems · Sep 1992