Hermes Medical Imaging Suite V5.4
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140269 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hermes Medical Imaging Suite V5.4 is a software-based medical imaging workstation. It is designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations.
This device is authorized under FDA 510(k) clearance K140269. It is classified as a system for emission computed tomography and is intended for use in the field of radiology.
Frequently asked questions
What is the primary function of the Hermes Medical Imaging Suite V5.4?
This device is a software-based medical imaging workstation designed to process, display, analyze, and manage medical imaging data. It is specifically intended for use in the field of radiology, particularly for data transferred from other acquisition stations or workstations.
What type of imaging data is this system designed to handle?
The suite is designed to manage nuclear medicine data and other medical imaging data. It is classified as a system for emission computed tomography.
Is this device authorized for clinical use?
Yes, the Hermes Medical Imaging Suite V5.4 is authorized under FDA 510(k) clearance K140269.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HERMES MEDICAL IMAGING SUITE V5.4 (K140269) - Innolitics, Hermes Medical Solutions - Hermia Molecular Imaging Software, Hermia-The all-in-one molecular imaging software suite
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140269 | Class II | Active |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
Sources (1)
- FDA 510(k) K140269 24 fields · synced Sep 21, 2026