Hybrid Viewer (00859873006240)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252477 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 Hybrid Viewer is a system for emission computed tomography used for viewing medical images. It is designed to display and analyze imaging data from computed tomography and emission tomography systems.
The device is supplied by Hermes Medical Solutions AB and is authorized under FDA 510(k) clearance with product code KPS. It is regulated under 21 CFR 892.1200 for emission computed tomography systems and is classified as Class II. The device is intended for use in radiology settings.
Frequently asked questions
What is the Hybrid Viewer used for?
The Hybrid Viewer is a system for emission computed tomography designed to display and analyze imaging data from computed tomography and emission tomography systems in radiology settings.
How is the Hybrid Viewer supplied?
The device is supplied by Hermes Medical Solutions AB and is authorized under FDA 510(k) clearance with product code KPS, regulated under 21 CFR 892.1200 for emission computed tomography systems.
What is the regulatory classification of the Hybrid Viewer?
The Hybrid Viewer is classified as Class II under FDA 510(k) clearance with product code KPS and is intended for use in radiology settings.
What is the model number of the Hybrid Viewer?
The Hybrid Viewer model number is 00859873006240, which distinguishes it from other similar products manufactured by Hermes Medical Solutions AB.
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: Hybrid Viewer - Hermes Medical Solutions, PDF Hermes Medical Solutions AB Chief Quality and Regulatory Affairs ..., Hybrid Viewer (00859873006240) (K252477) — FDA 510 (k) | Innolitics, Hybrid Viewer - Hermes Medical Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252477 | Class II | Active |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
Sources (1)
- FDA 510(k) K252477 24 fields · synced Sep 26, 2026