Cleared Traditional

K812638 - DIAGNOSTIC MEDICAL COMPUTER

K812638 is the FDA 510(k) clearance for DIAGNOSTIC MEDICAL COMPUTER by Diagnostic Resources, Inc.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K812638 · Diagnostic Resources, Inc. · Cardiovascular device
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Nov 1981
Decision
62d
Days
Class 2
Risk

K812638 is an FDA 510(k) clearance for the DIAGNOSTIC MEDICAL COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Diagnostic Resources, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - the FDA cardiovascular device 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Resources, Inc. devices

Submission Details

510(k) Number K812638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date November 16, 1981
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K812638.
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CARDIAC REVIEW STATION
K812515 · Diasonics, Inc. · Oct 1981
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K811414 · Electro-Catheter Corp. · Jun 1981