SIGNA PET/MR
K-Number: K163619 · 2017-02-14
ApplicantGe Medical Systems, LLC
Decision Date2017-02-14
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA PET/MR is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2017-02-14 under approval number K163619. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIGNA PET/MR?
SIGNA PET/MR is a medical device that received FDA 510(k) clearance on 2017-02-14. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K163619.
When was SIGNA PET/MR approved by the FDA?
SIGNA PET/MR received FDA 510(k) clearance on 2017-02-14, under approval number K163619.
What company makes SIGNA PET/MR?
SIGNA PET/MR is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for SIGNA PET/MR?
The FDA product code for SIGNA PET/MR is OUO.
Other Devices by Ge Medical Systems, LLC
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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.