Radlink GPS Pro成像
K号: K242161 · 2025-03-18
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器械摘要
Radlink GPS Pro Imaging is the device name listed in this FDA 510(k) record. The listed applicant is Radlink, Inc.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K242161. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Radlink GPS Pro Imaging?
Radlink GPS Pro Imaging is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Radlink, Inc.. The 510(k) number is K242161.
When did Radlink GPS Pro Imaging receive FDA 510(k) clearance?
Radlink GPS Pro Imaging received FDA 510(k) clearance on 2025-03-18, under 510(k) number K242161.
Who is the listed applicant for Radlink GPS Pro Imaging?
The FDA 510(k) record lists Radlink, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Radlink GPS Pro Imaging?
The FDA product code for Radlink GPS Pro Imaging is LLZ.
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相关器械（代码：LLZ）
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请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
官方来源
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