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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 the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2025-07-30 under 510(k) 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. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K243919.

When did Voxel Dosimetry (00859873006226) receive FDA 510(k) clearance?

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

Who is the listed applicant for Voxel Dosimetry (00859873006226)?

The FDA 510(k) record lists Hermes Medical Solutions AB as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Hermes Medical Solutions AB 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.

K253835AffinityK252477Hybrid Viewer (00859873006240)K241364Hybrid Viewer (00859873006189)K202882AffinityK193152AffinityK191216Voxel Dosimetry™ v1.0

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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