Cleared Traditional

PLANMED CYTOGUIDE

K973493 · Planmed OY · Radiology
Nov 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K973493 is an FDA 510(k) clearance for the PLANMED CYTOGUIDE, 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 November 10, 1997, 56 days after receiving the submission on September 15, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K973493 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1997
Decision Date November 10, 1997
Days to Decision 56 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