Cleared Traditional

K813002 - MAVIS C

K813002 is the FDA 510(k) clearance for MAVIS C by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code DXK) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - DXK Echocardiograph

All 35
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K813002.
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · Del Mar Avionics · Jun 1985
SKI 5000
K812646 · Smithkline Diagnostics, Inc. · Nov 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · Advanced Technology Laboratories, Inc. · Jan 1981