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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-04-02 under 510(k) 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. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K173639.

When did Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax receive FDA 510(k) clearance?

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

Who is the listed applicant for Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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