Pro Series Couch Software, Model MT-PRO100
FDA 510(k) K034054 · Med-Tec,Inc.
510(k) numberK034054
Submission
- Device name
- Pro Series Couch Software, Model MT-PRO100
- Applicant
- Med-Tec,Inc.
Orange City, IA, US - Received
- December 30, 2003
- Decision date
- February 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K981992 | Electron Wedge Model MT-EW-1000IXI · Traditional | 12/15/1998SE |
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Questions and answers
When was Pro Series Couch Software, Model MT-PRO100 cleared by the FDA?
Pro Series Couch Software, Model MT-PRO100 (K034054) received a 510(k) decision of Substantially Equivalent on February 20, 2004, 52 days after the submission was received.
What is the product code of K034054?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.