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Cine/View Plus Cardiology Workstation

by Prism Imaging, Inc.

510(k) K904977

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904977 Date25 Feb 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXK
Device Class
Class II
Regulation
21 CFR Part 870.2330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cine/View Plus Cardiology Workstation is an echocardiograph designed for clinical use. It functions as a specialized system for the processing and display of cardiovascular imaging data.

This device is identified by K-number K904977 and is classified as a class 2 medical device under regulation number 870.2330. It received FDA 510(k) clearance on February 25, 1991.

Other devices from Prism Imaging, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Cine/View Plus Cardiology Workstation?

    The Cine/View Plus is an echocardiograph system specifically engineered for clinical environments to facilitate the processing and display of cardiovascular imaging data.

  • What is the regulatory status of this cardiology workstation?

    The Cine/View Plus Cardiology Workstation is a class 2 medical device that received FDA 510(k) clearance on February 25, 1991, under K-number K904977.

  • Under which medical specialty is this device categorized?

    This device is categorized under the cardiovascular medical specialty and is classified as an echocardiograph, which is regulated under 21 CFR 870.2330.