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510(k) K053458

WEB1000 by Agfa Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2005
Date Received
December 13, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)

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