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510(k) K991435

AII-PRO 100 PLUS AND ALL-PRO 200 by All-Pro Imaging Corp. — Product Code IXW

K991435 is an FDA 510(k) premarket notification submitted by All-Pro Imaging Corp. for the device "AII-PRO 100 PLUS AND ALL-PRO 200". The FDA issued a decision of Substantially Equivalent on May 20, 1999. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. All-Pro Imaging Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1999
Date Received
April 26, 1999
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 All-Pro Imaging Corp.

  • K001314 — MEDSCOPE (July 25, 2000)
  • K001321 — ALL-PRO 2010 (May 16, 2000)
  • K911291 — ALL-PRO 100 (July 3, 1991)

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)
  • K023613 — AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (January 23, 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)

FDA data resources