Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 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 2019-10-17 under 510(k) 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. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K191216.

When did Voxel Dosimetry™ v1.0 receive FDA 510(k) clearance?

Voxel Dosimetry™ v1.0 received FDA 510(k) clearance on 2019-10-17, under 510(k) number K191216.

Who is the listed applicant for Voxel Dosimetry™ v1.0?

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™ v1.0?

The FDA product code for Voxel Dosimetry™ v1.0 is LLZ.

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)K243919Voxel Dosimetry (00859873006226)K241364Hybrid Viewer (00859873006189)K202882AffinityK193152Affinity

View all 13 devices →

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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.

↑