Hermes HD AQ Acquisition Station and Hermes Workstation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002782 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hermes HD AQ 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 HDAQ acquisition stations.
This device is supplied by Nuclear Diagnostics AB and has received FDA 510(k) clearance with product code LLZ. It is used in radiology settings and is available in version 3.4. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Frequently asked questions
What is the Hermes HD AQ Acquisition Station and Hermes Workstation used for?
The Hermes HD AQ Acquisition Station is designed to acquire nuclear medicine image data using a compatible gamma camera system. The Hermes Workstation processes, displays, analyzes, and manages nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations.
Is the Hermes HD AQ Acquisition Station and Workstation single-use or reusable?
The device is not specified as single-use or reusable in the provided information. No details regarding sterility or MRI safety are available.
What regulatory approvals does the Hermes HD AQ system have?
The device has received FDA 510(k) clearance with product code LLZ. It was cleared through the traditional review process and determined to be substantially equivalent to predicate devices.
What version of the Hermes HD AQ system is available?
The Hermes HD AQ Acquisition Station and Hermes Workstation is available in version 3.4, as specified in the device information.
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 Hd Aq Acquisition Station and Hermes Workstation, Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4, Ab Hermes HD Aq Acquisition Station And Hermes… | allmed.wiki, Nuclear Diagnostics Ab FDA Filings
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002782 | Class II | Active |
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Manufacturer
- Manufacturer
- Nuclear Diagnostics AB
Sources (1)
- FDA 510(k) K002782 24 fields · synced Sep 27, 2026