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FDA 510(k)

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

K-Number: K173639 · 2018-04-02

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2018-04-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-04-02 under approval number K173639. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax is a medical device that received FDA 510(k) clearance on 2018-04-02. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K173639.

When was Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax approved by the FDA?

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax received FDA 510(k) clearance on 2018-04-02, under approval number K173639.

What company makes Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax is manufactured by Siemens Medi Cal Solutions, Inc..

What is the FDA product code for Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

The FDA product code for Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax is OWB.

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Official Source

View on FDA Database →

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

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