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FDA 510(k)

Hybrid Viewer (00859873006240)

K-Number: K252477 · 2025-09-09

ApplicantHermes Medical Solutions AB
Decision Date2025-09-09
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hybrid Viewer (00859873006240) is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2025-09-09 under approval number K252477. 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 Hybrid Viewer (00859873006240)?

Hybrid Viewer (00859873006240) is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K252477.

When was Hybrid Viewer (00859873006240) approved by the FDA?

Hybrid Viewer (00859873006240) received FDA 510(k) clearance on 2025-09-09, under approval number K252477.

What company makes Hybrid Viewer (00859873006240)?

Hybrid Viewer (00859873006240) is manufactured by Hermes Medical Solutions AB.

What is the FDA product code for Hybrid Viewer (00859873006240)?

The FDA product code for Hybrid Viewer (00859873006240) is KPS.

Other Devices by Hermes Medical Solutions AB

K153056Hermes Medical Imaging Suite v5.6 K171719Hybrid3D K171681Hermes Medical Imaging Suite v5.7 K163687OLINDA EXM K163394Hybrid3D K181468Hybrid3D

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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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