FDA 510(k)

MAGNETOM Avantofit, MAGNETOM Skyrafit

K号: K162102 · 2016-11-22

决定日期2016-11-22

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

MAGNETOM Avantofit, MAGNETOM Skyrafit is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K162102. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAGNETOM Avantofit, MAGNETOM Skyrafit?

MAGNETOM Avantofit, MAGNETOM Skyrafit is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K162102.

When did MAGNETOM Avantofit, MAGNETOM Skyrafit receive FDA 510(k) clearance?

MAGNETOM Avantofit, MAGNETOM Skyrafit received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162102.

Who is the listed applicant for MAGNETOM Avantofit, MAGNETOM Skyrafit?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNETOM Avantofit, MAGNETOM Skyrafit?

The FDA product code for MAGNETOM Avantofit, MAGNETOM Skyrafit is LNH.

列明Siemens Medi Cal Solutions, Inc.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。

K193216syngo.CT 肺部计算机辅助诊断 K182639MOBILETT Elara Max K182517MULTIX Impact K181279Ysio Max K173639Luminos dRF Max，Luminos Agile Max，Uroskop Omnia Max，Multitom Rax K173408Mammomat Revelation

查看所有 14 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。