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510(k) K041521

VOLUME VIEWER PLUS by General Electric Medical Systems — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2004
Date Received
June 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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