Cleared Traditional

K011619 - PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT (FDA 510(k) Clearance)

K011619 · Planmeca Oy · Radiology device

Jun 2001

Decision

35d

Days

Class 2

Risk

K011619 is an FDA 510(k) clearance for the PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).

Submitted by Planmeca Oy (Addison, US). The FDA issued a Cleared decision on June 29, 2001, 35 days after receiving the submission on May 25, 2001.

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

Submission Details

510(k) Number	K011619 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 25, 2001
Decision Date	June 29, 2001
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement