Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021656 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 Hdaq Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The Hermes Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations.
This device is categorized as a computed emission tomography system and has received FDA 510(k) clearance. It is intended for use in a clinical setting for the management and analysis of medical imaging data.
Frequently asked questions
What is the primary function of the Hermes Hdaq Acquisition Station and Workstation?
The Hdaq Acquisition Station is designed to acquire nuclear medicine image data from compatible gamma camera systems. The Hermes Workstation is intended for the processing, display, analysis, and management of medical imaging data transferred from other acquisition stations or workstations.
What is the regulatory status of this device?
The Hermes Hdaq Acquisition Station and Hermes Workstation, version 3.4, has received FDA 510(k) clearance. It is classified as a computed emission tomography system under regulation number 892.1200.
In what environment is this system intended to be used?
This device is intended for use in a clinical setting. It is specifically designed to support the management and analysis of medical imaging data within professional healthcare environments.
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 Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4, HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 510 (k ..., Hermes Hd Aq Acquisition Station and Hermes Workstation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021656 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nuclear Diagnostics
Sources (1)
- FDA 510(k) K021656 24 fields · synced Sep 25, 2026