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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 the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Coroporation. It received FDA 510(k) clearance on 2017-10-06 under 510(k) 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. The listed applicant is Toshiba Medical Systems Coroporation. The 510(k) number is K172188.

When did Aquilion Prime SP, TSX-303B/1, v8.4 receive FDA 510(k) clearance?

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

Who is the listed applicant for Aquilion Prime SP, TSX-303B/1, v8.4?

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

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 records listing Toshiba Medical Systems Coroporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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