FDA 510(k)

ThermPix 熱視覺攝影機

K 號：K232462 · 2023-09-14

決定日期2023-09-14

產品代碼LHQ

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

ThermPix Thermovisual Camera is the device name listed in this FDA 510(k) record. The listed applicant is Usa Therm, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K232462. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ThermPix Thermovisual Camera?

ThermPix Thermovisual Camera is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Usa Therm, Inc.. The 510(k) number is K232462.

When did ThermPix Thermovisual Camera receive FDA 510(k) clearance?

ThermPix Thermovisual Camera received FDA 510(k) clearance on 2023-09-14, under 510(k) number K232462.

Who is the listed applicant for ThermPix Thermovisual Camera?

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

What is the FDA product code for ThermPix Thermovisual Camera?

The FDA product code for ThermPix Thermovisual Camera is LHQ.

其他以 Usa Therm, 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。

K213650ThermPix 熱視覺攝影機

相關器械（代碼：LHQ）

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。

K253911德瑪-2Neko Health AB K213650ThermPix 熱視覺攝影機Usa Therm, Inc.K212965Smile-100 系統Niramai Health Analytix Private Limited K212412IRIS-XPMedicore Co., Ltd.K200999Thermidas 紅外線系統 (ThIR-A615)Thermidas Americas, Inc.K181716互動熱像儀Intouch Technologies, Inc., D.B.A. Intouch Health

官方來源

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