V5M

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942296 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cypress System

  Class II

  FDA 510(k) K010950 Active Cleared 27 Jun 2001

• Quick-Clip Needle Guide

  Class II

  FDA 510(k) K903561 Active Cleared 5 Mar 1991

• Acuson Picture Archiving & Communication System Modification

  Class II

  FDA 510(k) K940285 Active Cleared 29 Apr 1994

• Acuson Model 3001

  Class II

  FDA 510(k) K935595 Active Cleared 2 Mar 1995

• Acuson S228 Transducer for Transcranial Doppler

  Class II

  FDA 510(k) K890055 Active Cleared 16 May 1989

• Acuson V714OR Transducer

  Class II

  FDA 510(k) K921341 Active Cleared 27 Nov 1992

See all devices from Acuson Corp. →

• Is the V5M ultrasound system designed for single-use or repeated use in clinical settings, and how does this affect its maintenance requirements?

  The V5M is explicitly described as a reusable medical device, intended for use in hospitals and diagnostic imaging centers. Since it is not single-use, it requires regular cleaning, disinfection, and maintenance as outlined in the manufacturer’s instructions to ensure proper function and patient safety. Reusable devices like this typically undergo scheduled servicing to maintain performance and compliance with clinical standards.

• What type of regulatory clearance does the V5M hold, and how does this relate to its intended use in radiology?

  The V5M received FDA 510(k) clearance in 1995 under the product code ITX, which categorizes it as a radiology device. This clearance was granted under the substantially equivalent determination, meaning it was deemed comparable to a previously approved predicate device. The Radiology (RA) Advisory Committee reviewed it, confirming its classification as a diagnostic ultrasound system for imaging internal body structures in clinical settings.

• Does the V5M come pre-sterilized, or is it intended to be sterilized before first use in a clinical environment?

  The V5M is not specified as sterile upon packaging, which means it is not pre-sterilized for immediate clinical use. Since it is a reusable device, it must undergo proper cleaning, disinfection, and sterilization procedures as required by clinical protocols before each use to ensure patient safety and device efficacy.

• What year was the V5M originally cleared by the FDA, and what does this mean for its ongoing compliance and updates?

  The V5M was cleared by the FDA in 1995 under K-number K942296, meaning it was originally evaluated for substantial equivalence to a predicate device at that time. While this indicates initial compliance, manufacturers of cleared devices must still adhere to ongoing regulatory requirements, including post-market surveillance and any necessary updates or modifications, to maintain compliance with current FDA standards.