Medical Device Manufacturer · US , Kirkland , WA

Alpinion Medical Systems Co., Ltd. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2011

Recent clearances: X-CUBE 50, X-CUBE 60, X-CUBE 70, X-CUBE 90, X-CUBE 50, X-CUBE 60

Total

Cleared

Denied

Alpinion Medical Systems Co., Ltd. has 26 FDA 510(k) cleared radiology devices. Based in Kirkland, US.

Last cleared in 2023. Active since 2011.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.

Alpinion Medical Systems Co., Ltd. is one of 13654 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Alpinion Medical Systems Co., Ltd.

26 devices

1-12 of 26

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Apr 27, 2026

Alpinion Medical Systems Co., Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Alpinion Medical Systems Co., Ltd.

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