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FDA 510(k)

UltraSight AI Guidance

K-Number: K223347 · 2023-07-24

Decision Date2023-07-24
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UltraSight AI Guidance is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasight, Inc.. It received FDA 510(k) clearance on 2023-07-24 under 510(k) 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. The listed applicant is Ultrasight, Inc.. The 510(k) number is K223347.

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

UltraSight AI Guidance received FDA 510(k) clearance on 2023-07-24, under 510(k) number K223347.

Who is the listed applicant for UltraSight AI Guidance?

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

What is the FDA product code for UltraSight AI Guidance?

The FDA product code for UltraSight AI Guidance is QJU.

Other records listing Ultrasight, Inc. 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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