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FDA 510(k)

Hermes Medical Imaging Suite v5.6

K-Number: K153056 · 2016-06-01

ApplicantHermes Medical Solutions AB
Decision Date2016-06-01
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hermes Medical Imaging Suite v5.6 is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2016-06-01 under approval number K153056. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hermes Medical Imaging Suite v5.6?

Hermes Medical Imaging Suite v5.6 is a medical device that received FDA 510(k) clearance on 2016-06-01. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K153056.

When was Hermes Medical Imaging Suite v5.6 approved by the FDA?

Hermes Medical Imaging Suite v5.6 received FDA 510(k) clearance on 2016-06-01, under approval number K153056.

What company makes Hermes Medical Imaging Suite v5.6?

Hermes Medical Imaging Suite v5.6 is manufactured by Hermes Medical Solutions AB.

What is the FDA product code for Hermes Medical Imaging Suite v5.6?

The FDA product code for Hermes Medical Imaging Suite v5.6 is KPS.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42127793 Ethical Responsibility in the Off-Label Use of AI in Medical Imaging. The Journal of clinical ethics (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by Hermes Medical Solutions AB

K171719Hybrid3D K171681Hermes Medical Imaging Suite v5.7 K163687OLINDA EXM K163394Hybrid3D K181468Hybrid3D K191216Voxel Dosimetry™ v1.0

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Related Devices (Code: KPS)

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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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