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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K230185
Device Name ANT-X System
Applicant
NDR Medical Technology Pte. Ltd.
75 Ayer Rajah Crescent, #02-19
Singapore,  SG 139935
Applicant Contact Ng Ka Wei
Correspondent
Alira Health
Avinguda Josep Tarradellas
123 (7th Floor)
Barcelona,  ES 08029
Correspondent Contact Ainoa Forteza
Regulation Number892.1650
Classification Product Code
OWB  
Date Received01/23/2023
Decision Date 06/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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