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FDA 510(k)

IODR1717 / IODR1417 / IODR1417-GF (數位平面X光檢測器)

K 號：K241346 · 2024-11-07

申請人Aspen Imaging Healthcare, Inc.
決定日期2024-11-07
產品代碼MQB
諮詢委員會RA
決定相當於

器材摘要

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Imaging Healthcare, Inc.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K241346. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Aspen Imaging Healthcare, Inc.. The 510(k) number is K241346.

When did IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) receive FDA 510(k) clearance?

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) received FDA 510(k) clearance on 2024-11-07, under 510(k) number K241346.

Who is the listed applicant for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

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

What is the FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

The FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) is MQB.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Aspen Imaging 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。

K241425AspenView

相關器械（代碼：MQB）

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。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) LimitedK250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

官方來源

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