510(k) K802888

RAYTHEON MEDICAL IMAGING by Machlett Laboratories, Inc. — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
November 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type