Multileaf Intensity Modulating Collimator
FDA 510(k) K940412 · Nomos Corp.
510(k) numberK940412
Submission
- Device name
- Multileaf Intensity Modulating Collimator
- Applicant
- Nomos Corp.
Sewickley, PA, US - Received
- January 27, 1994
- Decision date
- February 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Multileaf Intensity Modulating Collimator cleared by the FDA?
Multileaf Intensity Modulating Collimator (K940412) received a 510(k) decision of Substantially Equivalent on February 15, 1995, 384 days after the submission was received.
What is the product code of K940412?
The FDA product code is IXI – Block, Beam-Shaping, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5710.