Cleared Traditional

MAMEX DC MG11

K881505 · Orion Corp. · Radiology
Jun 1988
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K881505 is an FDA 510(k) clearance for the MAMEX DC MG11, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Orion Corp. (Conroe, US). The FDA issued a Cleared decision on June 10, 1988, 60 days after receiving the submission on April 11, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K881505 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1988
Decision Date June 10, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

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