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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 a medical device manufactured by Raysolution Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-01-27 under approval 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. It is manufactured by Raysolution Healthcare Co., Ltd.. The 510(k) number is K241266.

When was Imaging system of positron emission and X-ray computed tomography (DigitMI 930) approved by the FDA?

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

What company makes 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 manufactured by Raysolution Healthcare Co., Ltd..

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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Related PubMed Literature

PMID: 42086270 Abdominopelvic computed tomography during pregnancy and the risk of congenital malformations: protocol for a nationwide population-based cohort study in South Korea. BMJ open (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Official Source

View on FDA Database →

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