FDA 510(k)

Envision 3D：图像引导系统

K号: K162375 · 2016-12-29

决定日期2016-12-29

产品代码OLO

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决定实质等同

器械摘要

Envision 3D: Image Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2016-12-29 under 510(k) number K162375. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Envision 3D: Image Guidance System?

Envision 3D: Image Guidance System is a medical device that received FDA 510(k) clearance on 2016-12-29. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K162375.

When did Envision 3D: Image Guidance System receive FDA 510(k) clearance?

Envision 3D: Image Guidance System received FDA 510(k) clearance on 2016-12-29, under 510(k) number K162375.

Who is the listed applicant for Envision 3D: Image Guidance System?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Envision 3D: Image Guidance System?

The FDA product code for Envision 3D: Image Guidance System is OLO.

列明7D Surgical, 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。

K2104577D注册框架，7D Flex髂骨连接器，7D针引导块，7D 3.2 mm Steinmann针，7D髂嵴针夹与钥匙 K2105557D手术系统 - 钻孔引导 K2019667D手术FlashLock 1，7D手术Flex杆连接器 - 5.5 mm - 150 mm，7D手术Flex阵列 K1929457D手术系统颅部活检和心室导管放置应用 K1921407D手术系统 K1832767D手术系统

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