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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K253029
Device Name RW-1
Applicant
Mediott, Inc.
18-2 Shitamachi, Akagi Kagura Sacas
Shinjuku-Ku,  JP 162-0803
Applicant Contact Abe Takehiko
Correspondent
Mediott, Inc.
18-2 Shitamachi, Akagi Kagura Sacas
Shinjuku-Ku,  JP 162-0803
Correspondent Contact Abe Takehiko
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/19/2025
Decision Date 03/31/2026
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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