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510(k) K897151

ACUSON V328 AND C5432 TRANSDUCERS by Acuson Corp. — Product Code JTX

K897151 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "ACUSON V328 AND C5432 TRANSDUCERS". The FDA issued a decision of Substantially Equivalent on July 3, 1990. The device falls under product code JTX (Transport Systems, Anaerobic), a Class I device regulated under 21 CFR 866.2900. Acuson Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1990
Date Received
December 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport Systems, Anaerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Acuson Corp.

  • K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (November 22, 2002)
  • K022896 — CSV12 SOFTWARE VIEWER (October 3, 2002)
  • K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM (August 13, 2002)
  • K021497 — CYPRESS ULTRASOUND SYSTEM (July 9, 2002)
  • K010950 — CYPRESS SYSTEM (June 27, 2001)
  • K002807 — 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (December 1, 2000)
  • K992631 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (December 15, 1999)
  • K992580 — FETAL ASSESSMENT CAP (October 18, 1999)
  • K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (August 2, 1999)
  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)

Other clearances for product code JTX

  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K882637 — ACCU-CULSHURE TM (July 6, 1988)
  • K791724 — BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (October 17, 1979)
  • K781376 — STANDARDIZE TGCL & TGCH (September 14, 1978)
  • K780159 — ANASWAB (February 13, 1978)
  • K761241 — PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (December 30, 1976)
  • K760063 — SPECIMEN COLLECTOR, ANAEROBIC (August 3, 1976)

FDA data resources