FDA 510(k)

AQUILION CXL

K-Number: K112989 · 2012-04-10

ApplicantToshiba America Medical Systems, In.C

Decision Date2012-04-10

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AQUILION CXL 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 2012-04-10 under 510(k) number K112989. 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 CXL?

AQUILION CXL is a medical device that received FDA 510(k) clearance on 2012-04-10. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K112989.

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

AQUILION CXL received FDA 510(k) clearance on 2012-04-10, under 510(k) number K112989.

Who is the listed applicant for AQUILION CXL?

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 CXL?

The FDA product code for AQUILION CXL 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.