Med-Tec Rediset
FDA 510(k)Class II (US FDA 510(k))
by Medtec LLC
Identifiers
- 510(k) Number
- K952189 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Med-Tec Rediset is a medical device classified as an accelerator, linear, medical device. It is used in radiology settings for medical procedures.
The device is supplied by Medtec LLC and has FDA 510K clearance with device class 2. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Med-Tec Rediset used for?
The Med-Tec Rediset is a linear accelerator medical device designed for use in radiology settings during medical procedures. It is classified as a medical device that helps accelerate particles for various diagnostic and therapeutic applications.
Is the Med-Tec Rediset single-use or reusable?
The device data does not specify whether the Med-Tec Rediset is intended for single-use or reusable applications. This information would need to be obtained directly from the manufacturer or product documentation.
What regulatory approvals does the Med-Tec Rediset have?
The Med-Tec Rediset has FDA 510K clearance with device class 2. It was cleared through the traditional pathway with a decision code of SESE (Substantially Equivalent) on August 9, 1995, and is classified under product code IYE.
What are the storage requirements for the Med-Tec Rediset?
The device data does not provide specific information regarding storage conditions for the Med-Tec Rediset. Storage requirements would typically be detailed in the product's instructions for use, which should be consulted for proper handling and maintenance.
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 | K952189 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Medtec, Inc.
Sources (1)
- FDA 510(k) K952189 24 fields · synced Sep 21, 2026