FDA 510(k)

DG PACS

K 號：K152977 · 2016-01-25

決定日期2016-01-25

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

DG PACS is the device name listed in this FDA 510(k) record. The listed applicant is Dicom Grid, Inc.. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K152977. 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 DG PACS?

DG PACS is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Dicom Grid, Inc.. The 510(k) number is K152977.

When did DG PACS receive FDA 510(k) clearance?

DG PACS received FDA 510(k) clearance on 2016-01-25, under 510(k) number K152977.

Who is the listed applicant for DG PACS?

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

What is the FDA product code for DG PACS?

The FDA product code for DG 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。

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官方來源

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