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FDA 510(k)

DOSE TRACKING SYSTEM MODEL XIDF-DTS801

K-Number: K123097 · 2013-02-13

ApplicantToshiba America Medical Systems, In.C
Decision Date2013-02-13
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOSE TRACKING SYSTEM MODEL XIDF-DTS801 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 2013-02-13 under 510(k) number K123097. 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 DOSE TRACKING SYSTEM MODEL XIDF-DTS801?

DOSE TRACKING SYSTEM MODEL XIDF-DTS801 is a medical device that received FDA 510(k) clearance on 2013-02-13. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K123097.

When did DOSE TRACKING SYSTEM MODEL XIDF-DTS801 receive FDA 510(k) clearance?

DOSE TRACKING SYSTEM MODEL XIDF-DTS801 received FDA 510(k) clearance on 2013-02-13, under 510(k) number K123097.

Who is the listed applicant for DOSE TRACKING SYSTEM MODEL XIDF-DTS801?

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 DOSE TRACKING SYSTEM MODEL XIDF-DTS801?

The FDA product code for DOSE TRACKING SYSTEM MODEL XIDF-DTS801 is JAA.

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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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