FDA 510(k)

SYNAPSE 3D BASIC TOOLS

K-Number: K101662 · 2010-07-26

ApplicantFujifilm Medical System U.S.A., Inc.

Decision Date2010-07-26

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SYNAPSE 3D BASIC TOOLS 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 2010-07-26 under 510(k) number K101662. 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 BASIC TOOLS?

SYNAPSE 3D BASIC TOOLS is a medical device that received FDA 510(k) clearance on 2010-07-26. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K101662.

When did SYNAPSE 3D BASIC TOOLS receive FDA 510(k) clearance?

SYNAPSE 3D BASIC TOOLS received FDA 510(k) clearance on 2010-07-26, under 510(k) number K101662.

Who is the listed applicant for SYNAPSE 3D BASIC TOOLS?

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 BASIC TOOLS?

The FDA product code for SYNAPSE 3D BASIC TOOLS 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.