Voxel Dosimetry v1.0
K-Number: K191216 · 2019-10-17
ApplicantHermes Medical Solutions AB
Decision Date2019-10-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Voxel Dosimetry v1.0 is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2019-10-17 under approval number K191216. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Voxel Dosimetry v1.0?
Voxel Dosimetry v1.0 is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K191216.
When was Voxel Dosimetry v1.0 approved by the FDA?
Voxel Dosimetry v1.0 received FDA 510(k) clearance on 2019-10-17, under approval number K191216.
What company makes Voxel Dosimetry v1.0?
Voxel Dosimetry v1.0 is manufactured by Hermes Medical Solutions AB.
What is the FDA product code for Voxel Dosimetry v1.0?
The FDA product code for Voxel Dosimetry v1.0 is LLZ.
Other Devices by Hermes Medical Solutions AB
Related Devices (Code: LLZ)
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.