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510(k) K925885

AFP 17 X 4 AUTOMATIC FILM PROCESSOR by Afp Imaging Corp. — Product Code IXW

K925885 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "AFP 17 X 4 AUTOMATIC FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on June 9, 1993. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1993
Date Received
November 16, 1992
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 Afp Imaging Corp.

  • K123419 — EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (December 27, 2012)
  • K072357 — NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM (September 18, 2007)
  • K041120 — EV APAN DIGITAL, MODEL K1VSM2000 (August 30, 2004)
  • K030647 — EVA DIGITAL DENTAL X-RAY SYSTEM (March 20, 2003)
  • K014144 — EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (February 7, 2002)
  • K013176 — MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (October 16, 2001)
  • K974619 — SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (February 25, 1998)
  • K950288 — AUTOLASER MULTI FORMAT CAMERA (April 4, 1995)
  • K930761 — IMAGE-X 70 INTRAORAL X-RAY SYSTEM (May 25, 1993)
  • K925684 — OLYMP-X,X-RAY GENERATOR (February 2, 1993)

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)
  • K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (February 12, 2003)
  • K023825 — FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (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