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FDA 510(k)

INFINIX ANGIO WORKSTATION W/DTS SOFTWARE

K-Number: K132106 · 2013-11-12

ApplicantToshiba America Medical Systems, In.C
Decision Date2013-11-12
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINIX ANGIO WORKSTATION W/DTS SOFTWARE 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 2013-11-12 under 510(k) number K132106. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINIX ANGIO WORKSTATION W/DTS SOFTWARE?

INFINIX ANGIO WORKSTATION W/DTS SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-11-12. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K132106.

When did INFINIX ANGIO WORKSTATION W/DTS SOFTWARE receive FDA 510(k) clearance?

INFINIX ANGIO WORKSTATION W/DTS SOFTWARE received FDA 510(k) clearance on 2013-11-12, under 510(k) number K132106.

Who is the listed applicant for INFINIX ANGIO WORKSTATION W/DTS SOFTWARE?

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 INFINIX ANGIO WORKSTATION W/DTS SOFTWARE?

The FDA product code for INFINIX ANGIO WORKSTATION W/DTS SOFTWARE is JAA.

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Official Source

View on FDA Database →

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