Identifiers
- 510(k) Number
- K041543 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 GE Discovery ST is a computed tomography system designed for emission imaging, functioning as a combined PET/CT scanner. It integrates acquisition, reconstruction, and display capabilities for diagnostic procedures in radiology settings.
The device is supplied as a single-use system component, specifically the Highlander Cassette Electronics Module (H-CEM) board located in the Raptor chassis within the gantry framework. It is regulated under FDA 510(k) with substantial equivalence determination, and is intended for use in healthcare facilities in the United States for operating and servicing medical equipment.
Frequently asked questions
What is the GE Discovery ST used for?
The GE Discovery ST is a computed tomography system designed for emission imaging as a combined PET/CT scanner. It integrates acquisition, reconstruction, and display capabilities for diagnostic procedures in radiology settings.
How is the device supplied?
The device is supplied as a single-use system component, specifically the Highlander Cassette Electronics Module (H-CEM) board located in the Raptor chassis within the gantry framework.
Is this device single-use or reusable?
The GE Discovery ST is supplied as a single-use system component, specifically the Highlander Cassette Electronics Module (H-CEM) board. This means it is intended for one-time use and should not be reprocessed or reused.
What regulatory route did this device follow?
The GE Discovery ST was regulated under FDA 510(k) with a substantial equivalence determination. It was cleared through the traditional clearance pathway with a decision date of June 22, 2004, under K041543.
Where is this device intended for use?
The device is intended for use in healthcare facilities in the United States for operating and servicing medical equipment. It is designed for diagnostic procedures in radiology settings.
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: Discovery ST | GE HealthCare Service Shop USA, Discovery ST (4 Slice) | GE HealthCare Service Shop USA, GE Healthcare Discovery ST Service Manual (PDF) | FSELIB
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041543 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K041543 24 fields · synced Oct 6, 2026