Home / 510(k) Clearances / K841263

510(k) K841263

CARDIOSCAN - TM BEING APPLIED FOR by Interspec, Inc. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
March 26, 1984
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 Interspec, Inc.

  • K940671 — INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETE (November 22, 1994)
  • K924231 — INTERSPEC APOGEE CLA (June 14, 1993)
  • K915696 — INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE (November 24, 1992)
  • K920678 — ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER (April 2, 1992)
  • K911073 — PROBE REFILL KIT (June 6, 1991)
  • K910049 — INTERSPEC APOGEE, MODIFICATION (April 29, 1991)
  • K903839 — INTERSPEC APOGEE (November 16, 1990)
  • K900155 — INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER (October 5, 1990)
  • K892944 — INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 (July 19, 1989)
  • K890173 — INTERSPEC APOGEE (April 14, 1989)

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)
  • K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTS (February 25, 1991)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)