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510(k) K023613

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

K023613 is an FDA 510(k) premarket notification submitted by Alphatek Corp. for the device "AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036". The FDA issued a decision of Substantially Equivalent on January 23, 2003. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Alphatek Corp. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code IXW

  • K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (August 18, 2011)
  • K093503 — INTRAX FILM PROCESSOR (January 6, 2010)
  • K091628 — OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (August 21, 2009)
  • K024342 — RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (April 23, 2003)
  • K023825 — FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (February 12, 2003)
  • K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (February 12, 2003)
  • K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (September 30, 2002)
  • K002640 — FREEDOM AUTOMATIC FILM PROCESSOR (November 8, 2000)
  • K002404 — MICRO-MAX, MODEL 319 (August 30, 2000)
  • K001321 — ALL-PRO 2010 (May 16, 2000)

FDA data resources