Identifiers
- 510(k) Number
- K133657 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 Discovery Pet/Ct 710 is a System, Tomography, Computed, Emission device. It is designed to deliver detailed images with integrated CT and PET technology in a single system.
The device is supplied with a product code of KPS and is regulated under regulation number 892.1200. It has been cleared by the FDA with a 510K clearance, and its medical specialty description is Radiology. The device is intended for use in a clinical setting, with its advanced hybrid technology and user-friendly design making it an essential system for healthcare professionals.
Frequently asked questions
What is the Discovery PET/CT 710 used for?
The Discovery PET/CT 710 is used for delivering detailed images with integrated CT and PET technology in a single system, primarily in radiology applications.
Is the Discovery PET/CT 710 cleared by the FDA?
Yes, the Discovery PET/CT 710 has been cleared by the FDA with a 510K clearance, indicating it is substantially equivalent to a predicate device.
What is the product code for the Discovery PET/CT 710?
The product code for the Discovery PET/CT 710 is KPS, and it is regulated under regulation number 892.1200.
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: GE HealthCare Discovery 710 - Probo Medical, Discovery 710, 610, and Optima 560 16Sl Operating System, PET/CT | GE ..., GE HealthCare - Discovery PET/CT 710 Community, Manuals and ... - MedWrench
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133657 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K133657 24 fields · synced Oct 1, 2026