FDA 510(k)

モビレイ・パルスSEデジタルイメージングシステム

K番号: K191503 · 2019-09-04

決定日2019-09-04

製品コードOWB

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてPortavision Medical, LLCを記載するその他の記録

K212557Virtual C DRF-NEO Digital Imaging System K211191Virtual C DRF Digital Imaging System

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