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FDA 510(k)

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS

K-Number: K130542 · 2013-06-14

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2013-06-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K130542. 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 LUNG AND ABDOMEN ANALYSIS?

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K130542.

When did SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS receive FDA 510(k) clearance?

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS received FDA 510(k) clearance on 2013-06-14, under 510(k) number K130542.

Who is the listed applicant for SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS?

The FDA 510(k) record lists Fujifilm Medical System 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 LUNG AND ABDOMEN ANALYSIS?

The FDA product code for SYNAPSE 3D LUNG AND ABDOMEN 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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