Theratron 780C/1000 with Computerized Console Upgrade
FDA 510(k) K001006 · Mds Nordion
510(k) numberK001006
Submission
- Device name
- Theratron 780C/1000 with Computerized Console Upgrade
- Applicant
- Mds Nordion
Ottawa, CA - Received
- March 29, 2000
- Decision date
- April 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Theratron 780C/1000 with Computerized Console Upgrade cleared by the FDA?
Theratron 780C/1000 with Computerized Console Upgrade (K001006) received a 510(k) decision of Substantially Equivalent on April 27, 2000, 29 days after the submission was received.
What is the product code of K001006?
The FDA product code is IWB – System, Radiation Therapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5750.