Cleared Abbreviated

PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

K983659 · Planmed OY · Radiology
Nov 1998
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K983659 is an FDA 510(k) clearance for the PLANMED SOPHIE & PLANNED SOPHIE CLASSIC, 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 November 16, 1998, 28 days after receiving the submission on October 19, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K983659 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1998
Decision Date November 16, 1998
Days to Decision 28 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZH — System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1710