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FDA 510(k)

SYNAPSE 3D COLON ANALYSIS

K-Number: K123566 · 2013-01-22

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2013-01-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNAPSE 3D COLON ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2013-01-22 under 510(k) number K123566. 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 SYNAPSE 3D COLON ANALYSIS?

SYNAPSE 3D COLON ANALYSIS is a medical device that received FDA 510(k) clearance on 2013-01-22. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K123566.

When did SYNAPSE 3D COLON ANALYSIS receive FDA 510(k) clearance?

SYNAPSE 3D COLON ANALYSIS received FDA 510(k) clearance on 2013-01-22, under 510(k) number K123566.

Who is the listed applicant for SYNAPSE 3D COLON ANALYSIS?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNAPSE 3D COLON ANALYSIS?

The FDA product code for SYNAPSE 3D COLON ANALYSIS is LLZ.

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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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