FDA 510(k)

CAAS 工作站

K 號：K180019 · 2018-05-03

決定日期2018-05-03

產品代碼IZI

諮詢委員會RA

決定相當於

器材摘要

CAAS Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K180019. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAAS Workstation?

CAAS Workstation is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K180019.

When did CAAS Workstation receive FDA 510(k) clearance?

CAAS Workstation received FDA 510(k) clearance on 2018-05-03, under 510(k) number K180019.

Who is the listed applicant for CAAS Workstation?

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

What is the FDA product code for CAAS Workstation?

The FDA product code for CAAS Workstation is IZI.

其他以 Pie Medical Imaging BV 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。

K2503303mensio 工作站 K232147CAAS 工作站 K232007CAAS MR解決方案 K212376卡斯·喬爾迪亞 K181825CAAS MR解決方案 K162376CAAS MR 4D血流

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相關器械（代碼：IZI）

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。

K261037780 nm SPY 携帶式手持式成像 (SPY-PHI) 系統Stryker Endoscopy K253181SURGIMAGE SIM 1000H 荧光影像平台Surgimage Corporation K243645IC-Flow™影像系統 2.0Diagnostic Green GmbH K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986模斯IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003)；EXPLORER AIR® 無菌覆蓋 (8004)Surgvision GmbH

官方來源

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