Cleared Traditional

K941762 - INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) (FDA 510(k) Clearance)

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

K941762 · Hogan & Hartson · Cardiovascular device
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Feb 1995
Decision
317d
Days
Class 2
Risk

K941762 is an FDA 510(k) clearance for the INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on February 22, 1995 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hogan & Hartson devices

Submission Details

510(k) Number K941762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date February 22, 1995
Days to Decision 317 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 125d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 426
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