Cleared Traditional

K904977 - CINE/VIEW PLUS - CARDIOLOGY WORKSTATION

K904977 is an FDA 510(k) clearance for CINE/VIEW PLUS - CARDIOLOGY WORKSTATION, manufactured by Prism Imaging, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

FDA 510(k) Submission Details - K904977

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.

DXK Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K904977.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
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ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
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K904832 · Hewlett-Packard Co. · Apr 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
INTERSPEC APOGEE
K903839 · Interspec, Inc. · Nov 1990
MODEL MD-5 DOPPLER
K901592 · D. E. Hokanson, Inc. · Oct 1990