0909FCB, 1212FCA— 510(k) K212753

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K212753 for 0909FCB, 1212FCA, Substantially Equivalent on 2021-10-18. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-08-31
Decision date: 2021-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.