FDA 510(k)

Beamscan MR

K号: K191646 · 2020-02-21

申请人Ptw-Freiburg Physikalisch-Technische-Werkstaetten

决定日期2020-02-21

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Beamscan MR is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191646. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Beamscan MR?

Beamscan MR is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten. The 510(k) number is K191646.

When did Beamscan MR receive FDA 510(k) clearance?

Beamscan MR received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191646.

Who is the listed applicant for Beamscan MR?

The FDA 510(k) record lists Ptw-Freiburg Physikalisch-Technische-Werkstaetten as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Beamscan MR?

The FDA product code for Beamscan MR is IYE.

列明Ptw-Freiburg Physikalisch-Technische-Werkstaetten为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K213370设备名称：VERIQA 医疗设备监管文本翻译：设备名称：VERIQA 产品名称：[保留产品名称] 公司名称：[保留公司名称] FDA（美国食品药品监督管理局）：美国食品药品监督管理局 510(k)：510(k)申请 PMA：上市前批准 NCT：临床试验注册号 PMID：PubMed ID 标识符：[保留标识符] URL：[保留URL] 请注意，以上翻译保留了原文中的专有名词和缩写。K160405OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D

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