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FDA 510(k)

Aquilion Lightning, TSX-035A/4 and /5, V7.0

K-Number: K153263 · 2016-04-01

ApplicantToshibamedical Systems Corporation
Decision Date2016-04-01
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Lightning, TSX-035A/4 and /5, V7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K153263. 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 Lightning, TSX-035A/4 and /5, V7.0?

Aquilion Lightning, TSX-035A/4 and /5, V7.0 is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K153263.

When did Aquilion Lightning, TSX-035A/4 and /5, V7.0 receive FDA 510(k) clearance?

Aquilion Lightning, TSX-035A/4 and /5, V7.0 received FDA 510(k) clearance on 2016-04-01, under 510(k) number K153263.

Who is the listed applicant for Aquilion Lightning, TSX-035A/4 and /5, V7.0?

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

What is the FDA product code for Aquilion Lightning, TSX-035A/4 and /5, V7.0?

The FDA product code for Aquilion Lightning, TSX-035A/4 and /5, V7.0 is JAK.

Other records listing Toshibamedical Systems Corporation 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.

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Related Devices (Code: JAK)

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.

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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.

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