Cleared Traditional

MOBILE SOPHIE MODIFICATION

K934373 · Planmed OY · Radiology

Apr 1994

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K934373 is an FDA 510(k) clearance for the MOBILE SOPHIE MODIFICATION, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on April 7, 1994, 211 days after receiving the submission on September 8, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K934373 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 1993
Decision Date	April 07, 1994
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement