Cleared Traditional

POLARIX 2 AND POLARIX 2E

K884578 · Dyna-Med · Radiology

Feb 1989

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K884578 is an FDA 510(k) clearance for the POLARIX 2 AND POLARIX 2E, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Dyna-Med (Victoria, US). The FDA issued a Cleared decision on February 9, 1989, 100 days after receiving the submission on November 1, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K884578 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1988
Decision Date	February 09, 1989
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—