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FDA 510(k)

uAI EasyTriage-Rib

K-Number: K193271 · 2021-01-15

ApplicantShanghai United Imaging Intelligence Co., Ltd.
Decision Date2021-01-15
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uAI EasyTriage-Rib 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 2021-01-15 under 510(k) number K193271. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uAI EasyTriage-Rib?

uAI EasyTriage-Rib is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K193271.

When did uAI EasyTriage-Rib receive FDA 510(k) clearance?

uAI EasyTriage-Rib received FDA 510(k) clearance on 2021-01-15, under 510(k) number K193271.

Who is the listed applicant for uAI EasyTriage-Rib?

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 EasyTriage-Rib?

The FDA product code for uAI EasyTriage-Rib is QFM.

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.

K242292uAI Easy Triage ICHK240411uAI PortalK222755uMR 680

Related Devices (Code: QFM)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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