5D Viewer
K 號：K161955 · 2016-08-10
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器材摘要
5D Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K161955. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 5D Viewer?
5D Viewer is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K161955.
When did 5D Viewer receive FDA 510(k) clearance?
5D Viewer received FDA 510(k) clearance on 2016-08-10, under 510(k) number K161955.
Who is the listed applicant for 5D Viewer?
The FDA 510(k) record lists Samsung Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 5D Viewer?
The FDA product code for 5D Viewer is LLZ.
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其他以 Samsung Medison Co., Ltd. 為申請人之記錄
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相關器械（代碼：LLZ）
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官方來源
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