Cleared Traditional

K000454 - DIMEX 2 (FDA 510(k) Clearance)

K000454 · Planmeca Oy · Radiology device

Mar 2000

Decision

49d

Days

Class 2

Risk

K000454 is an FDA 510(k) clearance for the DIMEX 2. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).

Submitted by Planmeca Oy (Wood Dale, US). The FDA issued a Cleared decision on March 31, 2000, 49 days after receiving the submission on February 11, 2000.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K000454 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 11, 2000
Decision Date	March 31, 2000
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement