FDA 510(k) Applications Submitted by VATECH CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K170066 01/09/2017 Green16/Green18 (Model: PHT-65LHS) VATECH CO., LTD.
K100317 02/04/2010 DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO VATECH CO., LTD.
K130432 02/21/2013 PHT-6500, PHT-60CFO VATECH CO., LTD.
K130585 03/05/2013 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD.
K121236 04/24/2012 PAX-DUO3D PLUS, PCT-5000 VATECH CO., LTD.
K121400 05/10/2012 PAX-UNI3D, PHT-7500 VATECH CO., LTD.
K121412 05/11/2012 PAX-FLEX3D, PHT-7000 VATECH CO., LTD.
K101590 06/07/2010 DIGITAL FLAT PANEL X-RAY DETECTOR VATECH CO., LTD.
K122155 07/20/2012 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD.
K102078 07/26/2010 RADIOLOGICAL IMAGE PROCESSING SYSTEM VATECH CO., LTD.
K102102 07/27/2010 COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD.
K102124 07/29/2010 DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD.
K102196 07/29/2010 COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD.
K102259 08/10/2010 DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD.
K082350 08/15/2008 PAX-500 VATECH CO., LTD.
K132983 09/23/2013 TON-95LH, PAX-I3D ORTHO VATECH CO., LTD.
K123493 11/09/2012 VEX-S 100W INTRAORAL X-RAY SYSTEM VATECH CO., LTD.
K113672 12/13/2011 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD.
K073365 11/30/2007 DENTAL DIGITAL X-RAY IMAGING SYSTEM VATECH CO., LTD.
K090467 02/23/2009 DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D VATECH CO., LTD.
K092103 07/14/2009 DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) VATECH CO., LTD.
K092830 09/14/2009 DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 VATECH CO., LTD.


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