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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2022-11-22 under 510(k) 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. The listed applicant is GE Medical Systems SCS. The 510(k) number is K223152.

When did Vision 2, EVARVision, TrackVision 2, HeartVision 2 receive FDA 510(k) clearance?

Vision 2, EVARVision, TrackVision 2, HeartVision 2 received FDA 510(k) clearance on 2022-11-22, under 510(k) number K223152.

Who is the listed applicant for Vision 2, EVARVision, TrackVision 2, HeartVision 2?

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

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.

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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.

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