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FDA 510(k)

SYNAPSE 3D BRAIN PERFUSION

K-Number: K120637 · 2012-05-08

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2012-05-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNAPSE 3D BRAIN PERFUSION 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 2012-05-08 under 510(k) number K120637. 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 BRAIN PERFUSION?

SYNAPSE 3D BRAIN PERFUSION is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K120637.

When did SYNAPSE 3D BRAIN PERFUSION receive FDA 510(k) clearance?

SYNAPSE 3D BRAIN PERFUSION received FDA 510(k) clearance on 2012-05-08, under 510(k) number K120637.

Who is the listed applicant for SYNAPSE 3D BRAIN PERFUSION?

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 BRAIN PERFUSION?

The FDA product code for SYNAPSE 3D BRAIN PERFUSION 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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