MIM Monte Carlo Dosimetry
FDA 510(k) K232862 · Mim Software, Inc.
510(k) numberK232862
Submission
- Device name
- MIM Monte Carlo Dosimetry
- Applicant
- Mim Software, Inc.
Cleveland, OH, US - Received
- September 15, 2023
- Decision date
- May 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MIM Monte Carlo Dosimetry cleared by the FDA?
MIM Monte Carlo Dosimetry (K232862) received a 510(k) decision of Substantially Equivalent on May 13, 2024, 241 days after the submission was received.
What is the product code of K232862?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.