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510(k) K023613

AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 by Alphatek Corp. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2003
Date Received
October 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Alphatek Corp.

  • K931883 — AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 (August 23, 1993)
  • K931882 — MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR (August 23, 1993)
  • K925569 — AX-700LE AUTOMATIC X-RAY FILM PROCESSOR (January 15, 1993)
  • K924430 — AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 (November 27, 1992)

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