UltraSight AI Guidance
K-Number: K223347 · 2023-07-24
ApplicantUltrasight, Inc.
Decision Date2023-07-24
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
UltraSight AI Guidance is a medical device manufactured by Ultrasight, Inc.. It received FDA 510(k) clearance on 2023-07-24 under approval number K223347. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UltraSight AI Guidance?
UltraSight AI Guidance is a medical device that received FDA 510(k) clearance on 2023-07-24. It is manufactured by Ultrasight, Inc.. The 510(k) number is K223347.
When was UltraSight AI Guidance approved by the FDA?
UltraSight AI Guidance received FDA 510(k) clearance on 2023-07-24, under approval number K223347.
What company makes UltraSight AI Guidance?
UltraSight AI Guidance is manufactured by Ultrasight, Inc..
What is the FDA product code for UltraSight AI Guidance?
The FDA product code for UltraSight AI Guidance is QJU.
Related Devices (Code: QJU)
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.