FDA 510(k)

正电子发射和X射线计算机断层扫描成像系统（DigitMI 930）

K号: K241266 · 2025-01-27

决定日期2025-01-27

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Imaging system of positron emission and X-ray computed tomography (DigitMI 930) is the device name listed in this FDA 510(k) record. The listed applicant is Raysolution Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-01-27 under 510(k) number K241266. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Imaging system of positron emission and X-ray computed tomography (DigitMI 930)?

Imaging system of positron emission and X-ray computed tomography (DigitMI 930) is a medical device that received FDA 510(k) clearance on 2025-01-27. The listed applicant is Raysolution Healthcare Co., Ltd.. The 510(k) number is K241266.

When did Imaging system of positron emission and X-ray computed tomography (DigitMI 930) receive FDA 510(k) clearance?

Imaging system of positron emission and X-ray computed tomography (DigitMI 930) received FDA 510(k) clearance on 2025-01-27, under 510(k) number K241266.

Who is the listed applicant for Imaging system of positron emission and X-ray computed tomography (DigitMI 930)?

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

What is the FDA product code for Imaging system of positron emission and X-ray computed tomography (DigitMI 930)?

The FDA product code for Imaging system of positron emission and X-ray computed tomography (DigitMI 930) is KPS.

相关器械（代码：KPS）

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器械摘要

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相关器械（代码：KPS）

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