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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K253078
Device Name ART.1-US
Applicant
Seetreat Pty, Ltd.
320 Pitt St.
Sydney,  AU 2000
Applicant Contact Eric Qin
Correspondent
Seetreat Pty, Ltd.
320 Pitt St.
Sydney,  AU 2000
Correspondent Contact Eric Qin
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/23/2025
Decision Date 05/14/2026
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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