Cleared Traditional

MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000

K946261 · Scott Imaging Intl., Inc. · Radiology

Feb 1995

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K946261 is an FDA 510(k) clearance for the MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000, a Tube Mount, X-ray, Diagnostic (Class I — General Controls, product code IYB), submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on February 15, 1995, 64 days after receiving the submission on December 13, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1770.

Submission Details

510(k) Number	K946261 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 1994
Decision Date	February 15, 1995
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement