Cleared Traditional

K000428 - DIXI 2
(FDA 510(k) Clearance)

K000428 · Planmeca Oy · Radiology

Apr 2000

Decision

79d

Days

Class 2

Risk

K000428 is an FDA 510(k) clearance for the DIXI 2, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on April 28, 2000, 79 days after receiving the submission on February 9, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K000428 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2000
Decision Date	April 28, 2000
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement