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FDA 510(k)

MULTI-MODALITY IMAGE FUSION

K-Number: K120187 · 2012-04-06

ApplicantIgt, LLC Dba Eigen
Decision Date2012-04-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTI-MODALITY IMAGE FUSION is the device name listed in this FDA 510(k) record. The listed applicant is Igt, LLC Dba Eigen. It received FDA 510(k) clearance on 2012-04-06 under 510(k) number K120187. 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 MULTI-MODALITY IMAGE FUSION?

MULTI-MODALITY IMAGE FUSION is a medical device that received FDA 510(k) clearance on 2012-04-06. The listed applicant is Igt, LLC Dba Eigen. The 510(k) number is K120187.

When did MULTI-MODALITY IMAGE FUSION receive FDA 510(k) clearance?

MULTI-MODALITY IMAGE FUSION received FDA 510(k) clearance on 2012-04-06, under 510(k) number K120187.

Who is the listed applicant for MULTI-MODALITY IMAGE FUSION?

The FDA 510(k) record lists Igt, LLC Dba Eigen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTI-MODALITY IMAGE FUSION?

The FDA product code for MULTI-MODALITY IMAGE FUSION is LLZ.

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Related Devices (Code: 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.

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