FDA 510(k)

MapRT 注意：根據政策“medical-regulatory-v1”，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和URL將保持不變。

K 號：K231185 · 2023-06-23

決定日期2023-06-23

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

MapRT is the device name listed in this FDA 510(k) record. The listed applicant is Vision Rt, Ltd.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K231185. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MapRT?

MapRT is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Vision Rt, Ltd.. The 510(k) number is K231185.

When did MapRT receive FDA 510(k) clearance?

MapRT received FDA 510(k) clearance on 2023-06-23, under 510(k) number K231185.

Who is the listed applicant for MapRT?

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

What is the FDA product code for MapRT?

The FDA product code for MapRT is IYE.

其他以 Vision Rt, Ltd. 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。

K253012AlignRT Plus (8.0)K243301MapRT 注意：根據政策“medical-regulatory-v1”，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和URL將保持不變。K233622AlignRT Plus K212583AlignRT Plus K203387AlignRT Plus K193431AlignRT Plus

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相關器械（代碼：IYE）

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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