FDA 510(k)

SRT-100+

K 號：K173425 · 2018-03-23

決定日期2018-03-23

產品代碼JAD

諮詢委員會RA

決定相當於

器材摘要

SRT-100+ is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K173425. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SRT-100+?

SRT-100+ is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K173425.

When did SRT-100+ receive FDA 510(k) clearance?

SRT-100+ received FDA 510(k) clearance on 2018-03-23, under 510(k) number K173425.

Who is the listed applicant for SRT-100+?

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

What is the FDA product code for SRT-100+?

The FDA product code for SRT-100+ is JAD.

其他以 Sensus Healthcare, 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。

K190255Sensus Healthcare TVM 气球施用器 K182665Sensus TPS Workstation K182641Sensus IORT 系統

相關器械（代碼：JAD）

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。

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLC K241174INTRABEAM (700)；以及配件（INTRABEAM SMART Stand、INTRABEAM SMART 球形施用器、INTRABEAM 球形尺寸套装、INTRABEAM 针型施用器）Carl Zeiss Meditec, AG K230611X80 / RADiant / 光電治療系統 (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K182641Sensus IORT 系統Sensus Healthcare, Inc.K190255Sensus Healthcare TVM 气球施用器Sensus Healthcare, Inc.

官方來源

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