FDA · official record K122155Substantially Equivalent

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

Name: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM — FDA K122155
Creator: VATECH Co., Ltd.
Keywords: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, K122155, MUH, FDA

United StatesMUHVATECH Co., Ltd.

Verified

Official record identity

FDA application number: K122155
Decision date: September 04, 2012
Published decision: Substantially Equivalent

Classification

Product code: MUH

Published parties

Applicant: VATECH Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2012-07-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.