FDA 510(k)

PLANET Onco Dose

K-Number: K182966 · 2019-03-06

Decision Date2019-03-06

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PLANET Onco Dose is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft. It received FDA 510(k) clearance on 2019-03-06 under 510(k) number K182966. 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?

PLANET Onco Dose is a medical device that received FDA 510(k) clearance on 2019-03-06. The listed applicant is Dosisoft. The 510(k) number is K182966.

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

PLANET Onco Dose received FDA 510(k) clearance on 2019-03-06, under 510(k) number K182966.

Who is the listed applicant for PLANET Onco Dose?

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

What is the FDA product code for PLANET Onco Dose?

The FDA product code for PLANET Onco Dose is LLZ.

Other records listing Dosisoft 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 K241765PLANET Onco Dose (3.2)K231573ThinkQA (Edition 2)K191944MU2net 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.