Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC
FDA 510(k) K982549 · Radionics, Inc.
510(k) numberK982549
Submission
- Device name
- Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- July 21, 1998
- Decision date
- December 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC cleared by the FDA?
Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC (K982549) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 162 days after the submission was received.
What is the product code of K982549?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.