FDA 510(k)

科俄斯DS乳房用設備

K 號：K190442 · 2019-07-03

決定日期2019-07-03

產品代碼POK

諮詢委員會RA

決定相當於

器材摘要

Koios DS for Breast is the device name listed in this FDA 510(k) record. The listed applicant is Koios Medical, Inc.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K190442. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Koios DS for Breast?

Koios DS for Breast is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Koios Medical, Inc.. The 510(k) number is K190442.

When did Koios DS for Breast receive FDA 510(k) clearance?

Koios DS for Breast received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190442.

Who is the listed applicant for Koios DS for Breast?

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

What is the FDA product code for Koios DS for Breast?

The FDA product code for Koios DS for Breast is POK.

其他以 Koios Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253884科俄斯DS（3.8）K242130科俄斯DS K212616科俄斯DS

相關器械（代碼：POK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253884科俄斯DS（3.8）Koios Medical, Inc.K261519Sonio懷疑Sonio K254161自動主動脈瓣膜狭窄軟件（AutoAS）GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K251769RevealAI-肺Precision Medical Ventures, Inc. Dba Revealdx K252294胎兒心超掃描器（v1.2）Brightheart K250221中風感測 ASPECTS 軟體應用程序Circle Cardiovascular Imaging, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。