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510(k) K000159

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO by Agfa Corp. — Product Code IXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2000
Date Received
January 19, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

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  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K924459 — DIGISCAN 2 (December 17, 1992)
  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)