Identifiers
- 510(k) Number
- K050993 FDA 510(k)
- FDA Product Code
- LLZ 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 MMS Video Option is a device that provides video functionality for medical measurement systems. It is designed to capture and display video data as part of the overall measurement system.
This device is supplied by Medical Measurement Systems B.V. and is authorized under FDA 510K clearance with product code LLZ. It is intended for use in radiology settings and is not specified as single-use or reusable. The device is MRI safe and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the MMS Video Option used for?
The MMS Video Option is designed to capture and display video data as part of medical measurement systems, specifically intended for use in radiology settings to enhance diagnostic capabilities.
Is the MMS Video Option a single-use device?
The device is not specified as single-use or reusable in the provided information, so users should refer to the manufacturer's instructions for proper handling and usage guidelines.
What regulatory approvals does the MMS Video Option have?
The MMS Video Option is authorized under FDA 510K clearance with product code LLZ, received on May 26, 2005, and is classified under the Radiology advisory committee.
Is the MMS Video Option safe for MRI environments?
Yes, the device is MRI safe, making it suitable for use in magnetic resonance imaging environments without interfering with the imaging process or patient safety.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050993 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Measurement Systems B.V.
Sources (1)
- FDA 510(k) K050993 24 fields · synced Oct 6, 2026