FDA 510(k)

Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

K-Number: K241266 · 2025-01-27

ApplicantRaysolution Healthcare Co., Ltd.

Decision Date2025-01-27

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Official Source

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