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510(k) K002640

FREEDOM AUTOMATIC FILM PROCESSOR by J. Morita USA, Inc. — Product Code IXW

K002640 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "FREEDOM AUTOMATIC FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on November 8, 2000. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2000
Date Received
August 24, 2000
Clearance Type
Abbreviated
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

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  • K190509 — Lubrina 2 (March 4, 2020)
  • K173920 — LS OIL (October 11, 2018)
  • K171012 — Veraview X800 (December 19, 2017)
  • K170275 — Tri Auto ZX2 (September 11, 2017)
  • K120377 — ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (July 25, 2012)
  • K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (May 4, 2012)
  • K103697 — TORQTECH (January 20, 2012)
  • K090925 — MULTIPLE (APEX LOCATOR), MODEL RCM-7 (November 23, 2009)

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)
  • K002404 — MICRO-MAX, MODEL 319 (August 30, 2000)
  • K001321 — ALL-PRO 2010 (May 16, 2000)

FDA data resources