FDA 510(k)

MobileRay 脉冲 SE 数字成像系统

K号: K191503 · 2019-09-04

决定日期2019-09-04

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

MobileRay Pulse SE Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Portavision Medical, LLC. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K191503. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MobileRay Pulse SE Digital Imaging System?

MobileRay Pulse SE Digital Imaging System is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Portavision Medical, LLC. The 510(k) number is K191503.

When did MobileRay Pulse SE Digital Imaging System receive FDA 510(k) clearance?

MobileRay Pulse SE Digital Imaging System received FDA 510(k) clearance on 2019-09-04, under 510(k) number K191503.

Who is the listed applicant for MobileRay Pulse SE Digital Imaging System?

The FDA 510(k) record lists Portavision Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MobileRay Pulse SE Digital Imaging System?

The FDA product code for MobileRay Pulse SE Digital Imaging System is OWB.

列明Portavision Medical, LLC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。

K212557虚拟C DRF-NEO 数字成像系统 K211191虚拟C DRF数字成像系统

官方来源

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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。