Cleared Traditional

FLUOROSCAN/TM BY HEALTHMATE

K843920 · Healthmate, Inc. · Radiology

Feb 1985

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K843920 is an FDA 510(k) clearance for the FLUOROSCAN/TM BY HEALTHMATE, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Healthmate, Inc. (Northbrook, US). The FDA issued a Cleared decision on February 7, 1985, 125 days after receiving the submission on October 5, 1984. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K843920 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 1984
Decision Date	February 07, 1985
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—