Shimadzu Mobile X-Ray System MUX-100 Series
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001517 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 Shimadzu Mobile X-Ray System MUX-100 Series is a mobile X-ray system designed for diagnostic imaging. It features an inverter X-ray generator and a telescopic arm that allows for adjustable positioning of the X-ray tube.
This system is intended for use in hospital settings to facilitate mobile radiography. It is regulated under FDA 510(k) clearance as a Class 2 device.
Frequently asked questions
What is the primary purpose of the Shimadzu MUX-100 Series?
The system is designed for diagnostic imaging in hospital settings to facilitate mobile radiography, allowing clinicians to perform X-ray examinations at the patient's bedside.
What are the key mechanical features of this mobile X-ray system?
The system is equipped with an inverter X-ray generator and a telescopic arm, which provides the flexibility needed for adjustable positioning of the X-ray tube during imaging procedures.
What is the regulatory status of this device?
The Shimadzu Mobile X-Ray System MUX-100 Series is regulated under FDA 510(k) clearance as a Class 2 medical device, identified by k-number K001517.
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: SHIMADZU CORPORATION, SHIMADZU MUX-100D OPERATION MANUAL Pdf Download, MOBILEART MUX-100 SERIES SERVICE MANUAL Pdf Download, Shimadzu Mobile X-ray System MUX-100H | PDF | Radiography | X Ray - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001517 | Class II | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA 510(k) K001517 24 fields · synced Sep 24, 2026