Cleared Traditional

ALPHA STEREO

K934478 · Instrumentarium Corp. · Radiology
Jan 1995
Decision
504d
Days
Class 2
Risk

About This 510(k) Submission

K934478 is an FDA 510(k) clearance for the ALPHA STEREO, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Instrumentarium Corp. (Tuusula, Finland, FI). The FDA issued a Cleared decision on January 31, 1995, 504 days after receiving the submission on September 14, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K934478 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1993
Decision Date January 31, 1995
Days to Decision 504 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