UltraSight Guidance
K-Number: K251416 · 2025-12-17
ApplicantUltrasight , Ltd.
Decision Date2025-12-17
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
UltraSight Guidance is a medical device manufactured by Ultrasight , Ltd.. It received FDA 510(k) clearance on 2025-12-17 under approval number K251416. 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 Guidance?
UltraSight Guidance is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by Ultrasight , Ltd.. The 510(k) number is K251416.
When was UltraSight Guidance approved by the FDA?
UltraSight Guidance received FDA 510(k) clearance on 2025-12-17, under approval number K251416.
What company makes UltraSight Guidance?
UltraSight Guidance is manufactured by Ultrasight , Ltd..
What is the FDA product code for UltraSight Guidance?
The FDA product code for UltraSight Guidance is QJU.
Other Devices by Ultrasight , Ltd.
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.