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FDA 510(k)

Voxel Dosimetry (00859873006226)

K-Number: K243919 · 2025-07-30

ApplicantHermes Medical Solutions AB
Decision Date2025-07-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voxel Dosimetry (00859873006226) is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2025-07-30 under approval number K243919. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voxel Dosimetry (00859873006226)?

Voxel Dosimetry (00859873006226) is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K243919.

When was Voxel Dosimetry (00859873006226) approved by the FDA?

Voxel Dosimetry (00859873006226) received FDA 510(k) clearance on 2025-07-30, under approval number K243919.

What company makes Voxel Dosimetry (00859873006226)?

Voxel Dosimetry (00859873006226) is manufactured by Hermes Medical Solutions AB.

What is the FDA product code for Voxel Dosimetry (00859873006226)?

The FDA product code for Voxel Dosimetry (00859873006226) is QIH.

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Official Source

View on FDA Database →

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

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