510(k) K982536

PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE by Siemens Corp. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1998
Date Received
July 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type