FDA 510(k)

OPTIMA NM/CT 640

K-Number: K121019 · 2012-04-19

Decision Date2012-04-19

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OPTIMA NM/CT 640 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2012-04-19 under 510(k) number K121019. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMA NM/CT 640?

OPTIMA NM/CT 640 is a medical device that received FDA 510(k) clearance on 2012-04-19. The listed applicant is GE Healthcare. The 510(k) number is K121019.

When did OPTIMA NM/CT 640 receive FDA 510(k) clearance?

OPTIMA NM/CT 640 received FDA 510(k) clearance on 2012-04-19, under 510(k) number K121019.

Who is the listed applicant for OPTIMA NM/CT 640?

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

What is the FDA product code for OPTIMA NM/CT 640?

The FDA product code for OPTIMA NM/CT 640 is KPS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.