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VX1+

by Volta Medical France 510(k)

510(k) K223516

Product code DQK

Overview

The VX1+ is a medical software device classified under product code DQK and reviewed by the cardiovascular advisory committee. It was determined to be substantially equivalent through a traditional 510(k) clearance process.

The device received FDA 510(k) clearance under K223516 on January 21, 2023, following submission on November 22, 2022. It is manufactured by Volta Medical located at 65 Ave. Jules Cantini, Marseille, FR 13006.

Summary written by AI from registry data, 22 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223516 Date21 Jan 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Volta Medical

  • Volta AF-Xplorer II

    Class II

  • Volta AF-Xplorer

    Class II

  • VX1

    Class II

  • Volta AF-Xplorer

    Class II

Questions

  • What is the VX1+ device used for?

    The VX1+ is a medical software device classified under product code DQK and reviewed by the cardiovascular advisory committee, indicating its use in cardiovascular applications as part of its intended purpose.

  • How was the VX1+ cleared for market release?

    The VX1+ received FDA 510(k) clearance through a traditional submission process, determined to be substantially equivalent to a predicate device, as confirmed by the SESE decision code and K223516 clearance number.

  • Who manufactures the VX1+ and where is it located?

    The VX1+ is manufactured by Volta Medical, located at 65 Ave. Jules Cantini, Marseille, FR 13006, France, as specified in the device’s authorization and address details.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K223516 24 fields · synced 22 Oct 2026