Cleared Traditional

PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)

K021945 · Planmed OY · Radiology

Feb 2003

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K021945 is an FDA 510(k) clearance for the PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE), a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Planmed OY (Roselle, US). The FDA issued a Cleared decision on February 21, 2003, 253 days after receiving the submission on June 13, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K021945 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2002
Decision Date	February 21, 2003
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement