510(k) K946261

MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 by Scott Imaging Intl., Inc. — Product Code IYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1995
Date Received
December 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type