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FDA 510(k)

LUMINOS AGILE

K-Number: K111292 · 2011-06-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2011-06-03
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUMINOS AGILE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K111292. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMINOS AGILE?

LUMINOS AGILE is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K111292.

When did LUMINOS AGILE receive FDA 510(k) clearance?

LUMINOS AGILE received FDA 510(k) clearance on 2011-06-03, under 510(k) number K111292.

Who is the listed applicant for LUMINOS AGILE?

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

What is the FDA product code for LUMINOS AGILE?

The FDA product code for LUMINOS AGILE is JAA.

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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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