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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K250696
Device Name AccuCheck
Applicant
Manteia Technologies Co., Ltd.
Unit 3001-3005, #5 Huizhan N. Rd.
Xiamen,  CN 361008
Applicant Contact Chao Fang
Correspondent
Manteia Technologies Co., Ltd.
Unit 3001-3005, #5 Huizhan N. Rd.
Xiamen,  CN 361008
Correspondent Contact Chao Fang
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/07/2025
Decision Date 10/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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