FDA 510(k)

AQUILION PRIME

K-Number: K110066 · 2012-01-26

ApplicantToshiba America Medical Systems, In.C

Decision Date2012-01-26

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AQUILION PRIME is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K110066. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUILION PRIME?

AQUILION PRIME is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K110066.

When did AQUILION PRIME receive FDA 510(k) clearance?

AQUILION PRIME received FDA 510(k) clearance on 2012-01-26, under 510(k) number K110066.

Who is the listed applicant for AQUILION PRIME?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUILION PRIME?

The FDA product code for AQUILION PRIME is JAK.

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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.