Cleared Traditional

K060892 - GALILEOS
(FDA 510(k) Clearance)

K060892 · Sirona Dental Systems GmbH · Radiology

Apr 2006

Decision

11d

Days

Class 2

Risk

K060892 is an FDA 510(k) clearance for the GALILEOS, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on April 14, 2006, 11 days after receiving the submission on April 3, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K060892 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2006
Decision Date	April 14, 2006
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF