Cleared Traditional

K934063 - PANORAMIC X-RAY UNITS, MODIFICATION (FDA 510(k) Clearance)

K934063 · Planmeca Oy · Radiology device

Dec 1993

Decision

106d

Days

Class 2

Risk

K934063 is an FDA 510(k) clearance for the PANORAMIC X-RAY UNITS, MODIFICATION. This device is classified as 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 December 15, 1993, 106 days after receiving the submission on August 31, 1993.

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

Submission Details

510(k) Number	K934063 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 1993
Decision Date	December 15, 1993
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement