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FDA 510(k)

UltraSight Guidance

K-Number: K251416 · 2025-12-17

Decision Date2025-12-17
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UltraSight Guidance is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasight , Ltd.. It received FDA 510(k) clearance on 2025-12-17 under 510(k) 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. The listed applicant is Ultrasight , Ltd.. The 510(k) number is K251416.

When did UltraSight Guidance receive FDA 510(k) clearance?

UltraSight Guidance received FDA 510(k) clearance on 2025-12-17, under 510(k) number K251416.

Who is the listed applicant for UltraSight Guidance?

The FDA 510(k) record lists Ultrasight , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraSight Guidance?

The FDA product code for UltraSight Guidance is QJU.

Other records listing Ultrasight , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QJU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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