Cleared Traditional

K951883 - PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
(FDA 510(k) Clearance)

K951883 · Planmed OY · Radiology
May 1995
Decision
51d
Days
Class 2
Risk

K951883 is an FDA 510(k) clearance for the PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT, 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 May 24, 1995, 51 days after receiving the submission on April 3, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K951883 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1995
Decision Date May 24, 1995
Days to Decision 51 days
Submission Type Traditional
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