Medical Device Manufacturer · US , Denton , TX

Infinitt Co., Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2004

Recent clearances: INFINITT ULite, XELIS CARDIAC, XELIS FUSION

View 12 510(k) Devices ↓

Total

Cleared

Denied

Infinitt Co., Ltd. has 12 FDA 510(k) cleared radiology devices. Based in Denton, US.

Historical record: 12 cleared submissions from 2004 to 2017.

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

Regulatory submissions have been managed by Underwriters Laboratories, Inc., Entela, Inc. and O Tech, Inc..

Infinitt Co., Ltd. is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Infinitt Co., Ltd.

12 devices

1-12 of 12

INFINITT CARDIOLOGY PACS

STARPACS ORTHOPEDICS SYSTEM

K041500 · LLZ

Radiology · 14d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 15, 2026

Infinitt Co., Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Infinitt Co., Ltd.

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