Cleared Traditional

PLANMED NUANCE EXCEL

K111361 · Planmeca USA, Inc. · Radiology

Sep 2011

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K111361 is an FDA 510(k) clearance for the PLANMED NUANCE EXCEL, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Planmeca USA, Inc. (Roselle, US). The FDA issued a Cleared decision on September 23, 2011, 130 days after receiving the submission on May 16, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number	K111361 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2011
Decision Date	September 23, 2011
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF