Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, X-Ray, Stationary
510(k) Number K120034
Device Name RADIOGRAPHIC X-RAY SYSTEM
Applicant
Orich Medical Equipment (Tianjin Co., Ltd.
6840 SW 45th Ln #5
Miami,  FL  33155
Applicant Contact JUN PENG
Correspondent
Orich Medical Equipment (Tianjin Co., Ltd.
6840 SW 45th Ln #5
Miami,  FL  33155
Correspondent Contact JUN PENG
Regulation Number892.1680
Classification Product Code
KPR  
Date Received01/04/2012
Decision Date 04/17/2012
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
-
-