FDA 510(k)

Dose+ (1.0)

K-Number: K250064 · 2025-09-04

Decision Date2025-09-04

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Dose+ (1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Mvision AI OY. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K250064. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dose+ (1.0)?

Dose+ (1.0) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Mvision AI OY. The 510(k) number is K250064.

When did Dose+ (1.0) receive FDA 510(k) clearance?

Dose+ (1.0) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250064.

Who is the listed applicant for Dose+ (1.0)?

The FDA 510(k) record lists Mvision AI OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dose+ (1.0)?

The FDA product code for Dose+ (1.0) is MUJ.

Other records listing Mvision AI OY as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241490Contour+ (MVision AI Segmentation)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.