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510(k) K901658

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND by Hitachi Medical Corp. of America — Product Code DXK

K901658 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1990
Date Received
April 10, 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 Hitachi Medical Corp. of America

  • K994026 — EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER (March 29, 2000)
  • K991535 — CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (July 30, 1999)
  • K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS (June 18, 1999)
  • K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL (May 13, 1999)
  • K981434 — EUP-OL334 LAPARASCOPICPROBE (July 27, 1998)
  • K954220 — EUB-8000 (May 7, 1997)
  • K962308 — EUB-905 (July 17, 1996)
  • K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (December 22, 1995)
  • K954129 — SPECTRADIGITAL SERIES V250DSP (December 22, 1995)
  • K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (November 20, 1995)

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)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)

FDA data resources