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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K152813
Device Name FS-500DDR Medical Radiographic X-Ray System
Applicant
Orich Medical Equipment (Tianjin) Co., Ltd.
# 16 Cuiming Rd. Yat-Sen Scientific Industrial Park
Tianjin Economic Technological Developme,  CN 301726
Applicant Contact JU PENG
Correspondent
P&L Scientific, Inc.
6840 SW 45th Ln. Unit 5
Miami,  FL  33155
Correspondent Contact JUN PENG
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/28/2015
Decision Date 12/02/2016
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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