Discovery NM/CT 670 CZT
K-Number: K153402 · 2016-01-21
ApplicantGE Healthcare
Decision Date2016-01-21
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Discovery NM/CT 670 CZT is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-01-21 under approval number K153402. 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 Discovery NM/CT 670 CZT?
Discovery NM/CT 670 CZT is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by GE Healthcare. The 510(k) number is K153402.
When was Discovery NM/CT 670 CZT approved by the FDA?
Discovery NM/CT 670 CZT received FDA 510(k) clearance on 2016-01-21, under approval number K153402.
What company makes Discovery NM/CT 670 CZT?
Discovery NM/CT 670 CZT is manufactured by GE Healthcare.
What is the FDA product code for Discovery NM/CT 670 CZT?
The FDA product code for Discovery NM/CT 670 CZT is KPS.
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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.