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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K252909
Device Name Diagnostic X-Ray Equipment Model POCT22
Applicant
Ningbo Runyes Medical Instrument Co., Ltd.
# 456 Tonghui Rd.
Jiangbei Investment & Pioneering Park C
Ningbo Zhejiang,  CN 315000
Applicant Contact Weiqiong Fang
Correspondent
510K FDA, Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact Lee Strong
Regulation Number872.1800
Classification Product Code
EHD  
Date Received09/12/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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