Cleared Traditional

K010116 - PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
(FDA 510(k) Clearance)

K010116 · Planmed OY · Radiology

Mar 2001

Decision

58d

Days

Class 2

Risk

K010116 is an FDA 510(k) clearance for the PLANMED SOPHIE, PLANMED SOPHIE CLASSIC, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Planmed OY (Addison, US). The FDA issued a Cleared decision on March 15, 2001, 58 days after receiving the submission on January 16, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K010116 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2001
Decision Date	March 15, 2001
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement