FDA 510(k)

Affirm 横向上臂切片配件

K 號：K161575 · 2016-08-10

決定日期2016-08-10

產品代碼IZH

諮詢委員會RA

決定相當於

器材摘要

Affirm Lateral Arm Upright Biopsy Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Hologic. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K161575. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Affirm Lateral Arm Upright Biopsy Accessory?

Affirm Lateral Arm Upright Biopsy Accessory is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Hologic. The 510(k) number is K161575.

When did Affirm Lateral Arm Upright Biopsy Accessory receive FDA 510(k) clearance?

Affirm Lateral Arm Upright Biopsy Accessory received FDA 510(k) clearance on 2016-08-10, under 510(k) number K161575.

Who is the listed applicant for Affirm Lateral Arm Upright Biopsy Accessory?

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

What is the FDA product code for Affirm Lateral Arm Upright Biopsy Accessory?

The FDA product code for Affirm Lateral Arm Upright Biopsy Accessory is IZH.

其他以 Hologic 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。

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相關器械（代碼：IZH）

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。

K203509SMART 搜尋器Ims Giotto S.P.A.K202294Affirm 預測性切片Hologic, Inc.K191495組織切片定位器Fujifilm Corporation K161920舒適蓋Precision Dynamics Corporation K153486Affirm 預防性切片系統Hologic, Inc.

官方來源

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