M3 (Mirco-Multileaf Collimator
FDA 510(k) K004022 · Brainlab AG
510(k) numberK004022
Submission
- Device name
- M3 (Mirco-Multileaf Collimator
- Applicant
- Brainlab AG
Heimstetten, DE - Received
- December 27, 2000
- Decision date
- March 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was M3 (Mirco-Multileaf Collimator cleared by the FDA?
M3 (Mirco-Multileaf Collimator (K004022) received a 510(k) decision of Substantially Equivalent on March 26, 2002, 454 days after the submission was received.
What is the product code of K004022?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.