FDA 510(k)

Aquilion Prime SP, TSX-303B/1, v8.4

K-Number: K172188 · 2017-10-06

ApplicantToshiba Medical Systems Coroporation

Decision Date2017-10-06

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Aquilion Prime SP, TSX-303B/1, v8.4 is a medical device manufactured by Toshiba Medical Systems Coroporation. It received FDA 510(k) clearance on 2017-10-06 under approval number K172188. 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 SP, TSX-303B/1, v8.4?

Aquilion Prime SP, TSX-303B/1, v8.4 is a medical device that received FDA 510(k) clearance on 2017-10-06. It is manufactured by Toshiba Medical Systems Coroporation. The 510(k) number is K172188.

When was Aquilion Prime SP, TSX-303B/1, v8.4 approved by the FDA?

Aquilion Prime SP, TSX-303B/1, v8.4 received FDA 510(k) clearance on 2017-10-06, under approval number K172188.

What company makes Aquilion Prime SP, TSX-303B/1, v8.4?

Aquilion Prime SP, TSX-303B/1, v8.4 is manufactured by Toshiba Medical Systems Coroporation.

What is the FDA product code for Aquilion Prime SP, TSX-303B/1, v8.4?

The FDA product code for Aquilion Prime SP, TSX-303B/1, v8.4 is JAK.

Other Devices by Toshiba Medical Systems Coroporation

K170909Infinix INFX-8000V, V6.40

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.