FDA 510(k)

Qraycam PRO

K-Number: K221275 · 2024-09-04

Decision Date2024-09-04

Product CodeNBL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Qraycam PRO is the device name listed in this FDA 510(k) record. The listed applicant is AIOBIO Co., Ltd.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K221275. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qraycam PRO?

Qraycam PRO is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is AIOBIO Co., Ltd.. The 510(k) number is K221275.

When did Qraycam PRO receive FDA 510(k) clearance?

Qraycam PRO received FDA 510(k) clearance on 2024-09-04, under 510(k) number K221275.

Who is the listed applicant for Qraycam PRO?

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

What is the FDA product code for Qraycam PRO?

The FDA product code for Qraycam PRO is NBL.

Other records listing AIOBIO 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.

K183121Qraypen

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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.