FDA 510(k)

AQUILION ONE VISION, V4.90

K-Number: K122109 · 2012-09-21

ApplicantToshiba America Medical Systems, In.C

Decision Date2012-09-21

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AQUILION ONE VISION, V4.90 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 2012-09-21 under 510(k) number K122109. 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 ONE VISION, V4.90?

AQUILION ONE VISION, V4.90 is a medical device that received FDA 510(k) clearance on 2012-09-21. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K122109.

When did AQUILION ONE VISION, V4.90 receive FDA 510(k) clearance?

AQUILION ONE VISION, V4.90 received FDA 510(k) clearance on 2012-09-21, under 510(k) number K122109.

Who is the listed applicant for AQUILION ONE VISION, V4.90?

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 ONE VISION, V4.90?

The FDA product code for AQUILION ONE VISION, V4.90 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.