PLANET Onco Dose (3.2)
FDA 510(k) K241765 · Dosisoft SA
510(k) numberK241765
Submission
- Device name
- PLANET Onco Dose (3.2)
- Applicant
- Dosisoft SA
Cachan, FR - Received
- June 20, 2024
- Decision date
- March 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K182966 | PLANET Onco DoseLLZ · Traditional | 03/06/2019SE |
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Questions and answers
When was PLANET Onco Dose (3.2) cleared by the FDA?
PLANET Onco Dose (3.2) (K241765) received a 510(k) decision of Substantially Equivalent on March 14, 2025, 267 days after the submission was received.
What is the product code of K241765?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.