Cleared Traditional

K813002 - MAVIS C (FDA 510(k) Clearance)

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

K813002 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Mar 1982
Decision
126d
Days
Class 2
Risk

K813002 is an FDA 510(k) clearance for the MAVIS C. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2330 - 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K813002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date March 01, 1982
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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.