Cleared Traditional

PLANMED SOPHIE AND SOPHIE CLASSIC

K991826 · Planmed OY · Radiology

Aug 1999

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K991826 is an FDA 510(k) clearance for the PLANMED SOPHIE AND SOPHIE CLASSIC, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Planmed OY (Wood Dale, US). The FDA issued a Cleared decision on August 10, 1999, 74 days after receiving the submission on May 28, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K991826 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 1999
Decision Date	August 10, 1999
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement