Cleared Traditional

CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977) - FDA 510(k) Clearance

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

K904977 · Prism Imaging, Inc. · Cardiovascular device
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Feb 1991
Decision
116d
Days
Class 2
Risk

K904977 is an FDA 510(k) clearance for the CINE/VIEW PLUS - CARDIOLOGY WORKSTATION. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Prism Imaging, Inc. (Washington, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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. Standard predicate reliance. 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 Prism Imaging, Inc. devices

Submission Details

510(k) Number K904977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1990
Decision Date February 25, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 14
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K904977.
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