FDA 510(k)

DICOM Viewer

K-Number: K153653 · 2016-04-13

Decision Date2016-04-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DICOM Viewer is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2016-04-13 under approval number K153653. 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 DICOM Viewer?

DICOM Viewer is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by Brainlab AG. The 510(k) number is K153653.

When was DICOM Viewer approved by the FDA?

DICOM Viewer received FDA 510(k) clearance on 2016-04-13, under approval number K153653.

What company makes DICOM Viewer?

DICOM Viewer is manufactured by Brainlab AG.

What is the FDA product code for DICOM Viewer?

The FDA product code for DICOM Viewer is LLZ.

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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.