Vision 2, EVARVision, TrackVision 2, HeartVision 2
K-Number: K223152 · 2022-11-22
ApplicantGE Medical Systems SCS
Decision Date2022-11-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vision 2, EVARVision, TrackVision 2, HeartVision 2 is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2022-11-22 under approval number K223152. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vision 2, EVARVision, TrackVision 2, HeartVision 2?
Vision 2, EVARVision, TrackVision 2, HeartVision 2 is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by GE Medical Systems SCS. The 510(k) number is K223152.
When was Vision 2, EVARVision, TrackVision 2, HeartVision 2 approved by the FDA?
Vision 2, EVARVision, TrackVision 2, HeartVision 2 received FDA 510(k) clearance on 2022-11-22, under approval number K223152.
What company makes Vision 2, EVARVision, TrackVision 2, HeartVision 2?
Vision 2, EVARVision, TrackVision 2, HeartVision 2 is manufactured by GE Medical Systems SCS.
What is the FDA product code for Vision 2, EVARVision, TrackVision 2, HeartVision 2?
The FDA product code for Vision 2, EVARVision, TrackVision 2, HeartVision 2 is LLZ.
Other Devices by GE Medical Systems SCS
Related Devices (Code: LLZ)
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.