Identifiers
- 510(k) Number
- K063283 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Definium 5000 X-Ray System is a solid state X-ray imager, classified as a digital flat panel imager. It is designed to capture diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, and extremities in both adult and pediatric subjects.
This system is intended for use by qualified and trained medical professionals. It is regulated as a Class 2 radiology device under FDA 510(k) clearance K063283.
Frequently asked questions
What is the primary purpose of the Definium 5000 X-Ray System?
This system is a digital flat panel imager used to capture diagnostic radiographic exposures. It is indicated for imaging the skull, spinal column, chest, abdomen, and extremities in both adult and pediatric patients.
Who is authorized to operate this X-ray system?
The Definium 5000 is intended for use exclusively by qualified and trained medical professionals to ensure safe and accurate diagnostic imaging.
What is the regulatory classification of this device?
The system is regulated as a Class 2 radiology device. It received FDA 510(k) clearance under reference number K063283.
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: K063283 FDA 510(k) - DEFINIUM 5000 X-RAY SYSTEM | Sedecal., Sa., DEFINIUM 5000 X-RAY SYSTEM (K063283) — FDA 510(k) | Innolitics, GE DEFINIUM 5000 OPERATOR'S MANUAL Pdf Download, PDF K063283 - Definium 5000 X-ray System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063283 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sedecal., Sa.
Sources (1)
- FDA 510(k) K063283 24 fields · synced Sep 23, 2026