Identifiers
- 510(k) Number
- K160354 FDA 510(k)
- FDA Product Code
- PGY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MX50T(MX50TQS) is a diagnostic radiology display. It is designed to function as a medical imaging monitor for the visualization of radiological data.
This device is classified as a Class 2 medical device under regulation number 892.2050. It has received FDA 510(k) clearance under K160354.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160354 | Class II | Active |
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Manufacturer
- Manufacturer
- Wide Corporation
Sources (1)
- FDA 510(k) K160354 24 fields · synced Sep 23, 2026