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510(k) K904976

CINE'VIEW - STRESS ECHO & IMAGE REVIEW by Prism Imaging, Inc. — Product Code DXK

K904976 is an FDA 510(k) premarket notification submitted by Prism Imaging, Inc. for the device "CINE'VIEW - STRESS ECHO & IMAGE REVIEW". The FDA issued a decision of Substantially Equivalent on February 25, 1991. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Prism Imaging, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1991
Date Received
November 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

Other clearances by Prism Imaging, Inc.

  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)
  • K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTS (February 25, 1991)

Other clearances for product code DXK

  • K181042 — Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (May 17, 2018)
  • K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz Intr (February 26, 2016)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K913209 — ACCESSORY TO GENESIS III (GCFM) (May 15, 1992)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)
  • K904832 — MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (April 22, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)
  • K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTS (February 25, 1991)

FDA data resources