Identifiers
- 510(k) Number
- K173602 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Optima XR240amx, AutoGrid is a mobile X-ray system designed for diagnostic radiographic imaging. It is a self-contained, battery-operated unit equipped with digital detectors and advanced image processing to capture high-resolution images with fine detail and contrast.
This device is intended for use in clinical settings requiring portable radiographic imaging. It is supplied as a complete system and is regulated under FDA 510(k) clearance as a Class II device. The system is designed for single-patient use components where applicable, and storage conditions should follow manufacturer guidelines. MRI safety information is not specified in the provided data.
Frequently asked questions
What is the Optima XR240amx, AutoGrid used for?
It is a mobile X-ray system designed for diagnostic radiographic imaging in clinical settings requiring portable radiographic imaging.
How is the device supplied?
It is supplied as a complete system, self-contained and battery-operated, equipped with digital detectors and advanced image processing.
Is the device single-use or reusable?
The system is designed for single-patient use components where applicable, though the overall system is intended for repeated clinical use.
What are the storage conditions?
Storage conditions should follow manufacturer guidelines, though specific environmental parameters are not detailed in the provided data.
What is the regulatory classification?
It is regulated under FDA 510(k) clearance as a Class II device, with a traditional clearance type and substantially equivalent decision.
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 OPTIMA XR240AMX OPERATOR'S MANUAL Pdf Download, Ge Optima XR240amx Manuals | ManualsLib, PDF Optima™ XR240amx - GE Healthcare, PDF radBF245 - GE Healthcare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173602 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K173602 24 fields · synced Oct 6, 2026