FDA 510(k)

NEMIO XG, SAA-580A

K-Number: K061605 · 2006-06-22

ApplicantToshiba America Medical Systems, In.C

Decision Date2006-06-22

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NEMIO XG, SAA-580A 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 2006-06-22 under 510(k) number K061605. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEMIO XG, SAA-580A?

NEMIO XG, SAA-580A is a medical device that received FDA 510(k) clearance on 2006-06-22. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K061605.

When did NEMIO XG, SAA-580A receive FDA 510(k) clearance?

NEMIO XG, SAA-580A received FDA 510(k) clearance on 2006-06-22, under 510(k) number K061605.

Who is the listed applicant for NEMIO XG, SAA-580A?

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 NEMIO XG, SAA-580A?

The FDA product code for NEMIO XG, SAA-580A is IYN.

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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.