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FDA 510(k)

uAI Easy Triage ICH

K-Number: K242292 · 2024-09-24

Decision Date2024-09-24
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uAI Easy Triage ICH is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K242292. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uAI Easy Triage ICH?

uAI Easy Triage ICH is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K242292.

When did uAI Easy Triage ICH receive FDA 510(k) clearance?

uAI Easy Triage ICH received FDA 510(k) clearance on 2024-09-24, under 510(k) number K242292.

Who is the listed applicant for uAI Easy Triage ICH?

The FDA 510(k) record lists Shanghai United Imaging Intelligence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uAI Easy Triage ICH?

The FDA product code for uAI Easy Triage ICH is QAS.

Other records listing Shanghai United Imaging Intelligence Co., 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: QAS)

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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