Cleared Traditional

MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ

K981641 · Instrumentarium Corp. · Radiology

Jul 1998

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K981641 is an FDA 510(k) clearance for the MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on July 17, 1998, 70 days after receiving the submission on May 8, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K981641 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1998
Decision Date	July 17, 1998
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement