FDA 510(k)

PLANET Onco Dose (3.2)

K-Number: K241765 · 2025-03-14

Decision Date2025-03-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PLANET Onco Dose (3.2) is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft SA. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K241765. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANET Onco Dose (3.2)?

PLANET Onco Dose (3.2) is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Dosisoft SA. The 510(k) number is K241765.

When did PLANET Onco Dose (3.2) receive FDA 510(k) clearance?

PLANET Onco Dose (3.2) received FDA 510(k) clearance on 2025-03-14, under 510(k) number K241765.

Who is the listed applicant for PLANET Onco Dose (3.2)?

The FDA 510(k) record lists Dosisoft SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLANET Onco Dose (3.2)?

The FDA product code for PLANET Onco Dose (3.2) is LLZ.

Other records listing Dosisoft SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252937ThinkQA 3 K231573ThinkQA (Edition 2)K191944MU2net K182966PLANET Onco Dose K180106ThinkQA

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.