Hewlett-Packard CentralVue Software

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964832 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the CentralVue Software used for?

  CentralVue Software is a computer program designed for use with remote medical devices. It processes data from connected equipment to support clinical monitoring and analysis, helping clinicians make informed decisions based on the collected information.

• How is the CentralVue Software supplied and what are its sterility requirements?

  The software is supplied in a non-sterile format and is intended for single use. It does not require sterilization before use, but should be stored in a dry environment to maintain its functionality and prevent damage to the digital media.

• Is the CentralVue Software MRI safe and what are its storage requirements?

  The CentralVue Software is not MRI safe and should not be used in MRI environments. It should be stored in a dry environment to protect the digital media from moisture damage that could compromise the software's functionality.

• What is the regulatory classification of the CentralVue Software?

  The CentralVue Software is regulated as a Class II medical device and has received FDA 510(k) clearance with the K number K964832. It was determined to be substantially equivalent to other devices in its product code category DSI.