PET Digital Gating
K-Number: K180318 · 2018-04-11
ApplicantGe Medical Systems, LLC
Decision Date2018-04-11
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PET Digital Gating is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2018-04-11 under approval number K180318. 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 PET Digital Gating?
PET Digital Gating is a medical device that received FDA 510(k) clearance on 2018-04-11. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K180318.
When was PET Digital Gating approved by the FDA?
PET Digital Gating received FDA 510(k) clearance on 2018-04-11, under approval number K180318.
What company makes PET Digital Gating?
PET Digital Gating is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for PET Digital Gating?
The FDA product code for PET Digital Gating 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.