FDA 510(k)

ONIS-PACS

K 號：K181318 · 2018-08-13

決定日期2018-08-13

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

ONIS-PACS is the device name listed in this FDA 510(k) record. The listed applicant is Digitalcore Co., Ltd.. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K181318. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ONIS-PACS?

ONIS-PACS is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Digitalcore Co., Ltd.. The 510(k) number is K181318.

When did ONIS-PACS receive FDA 510(k) clearance?

ONIS-PACS received FDA 510(k) clearance on 2018-08-13, under 510(k) number K181318.

Who is the listed applicant for ONIS-PACS?

The FDA 510(k) record lists Digitalcore Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONIS-PACS?

The FDA product code for ONIS-PACS is LLZ.

相關器械（代碼：LLZ）

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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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