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 a medical device manufactured by Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2024-09-24 under approval 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. It is manufactured by Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K242292.
When was uAI Easy Triage ICH approved by the FDA?
uAI Easy Triage ICH received FDA 510(k) clearance on 2024-09-24, under approval number K242292.
What company makes uAI Easy Triage ICH?
uAI Easy Triage ICH is manufactured by Shanghai United Imaging Intelligence Co., Ltd..
What is the FDA product code for uAI Easy Triage ICH?
The FDA product code for uAI Easy Triage ICH is QAS.
Other Devices by Shanghai United Imaging Intelligence Co., Ltd.
Related Devices (Code: QAS)
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.