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FDA 510(k)

FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II

K-Number: K013218 · 2001-12-20

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2001-12-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II 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 2001-12-20 under 510(k) number K013218. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II?

FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K013218.

When did FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II receive FDA 510(k) clearance?

FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013218.

Who is the listed applicant for FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II?

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 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II?

The FDA product code for FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II is MQB.

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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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