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FDA 510(k)

TCT-300S - UPGRADE

K-Number: K900233 · 1990-02-26

ApplicantToshiba America Medical Systems, In.C
Decision Date1990-02-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCT-300S - UPGRADE 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 1990-02-26 under 510(k) number K900233. 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 TCT-300S - UPGRADE?

TCT-300S - UPGRADE is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K900233.

When did TCT-300S - UPGRADE receive FDA 510(k) clearance?

TCT-300S - UPGRADE received FDA 510(k) clearance on 1990-02-26, under 510(k) number K900233.

Who is the listed applicant for TCT-300S - UPGRADE?

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 TCT-300S - UPGRADE?

The FDA product code for TCT-300S - UPGRADE 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.

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