Cleared Special

K162552 - EVS 3643, EVS 3643G
(FDA 510(k) Clearance)

K162552 · DRTECH Corporation · Radiology

Dec 2016

Decision

80d

Days

Class 2

Risk

K162552 is an FDA 510(k) clearance for the EVS 3643, EVS 3643G. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB).

Submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on December 2, 2016, 80 days after receiving the submission on September 13, 2016.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K162552 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2016
Decision Date	December 02, 2016
Days to Decision	80 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF