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510(k) K950043

JPI AUTOMATIC X-RAY FILM PROCESSOR by Jpi Healthcare Co, Ltd. — Product Code IXW

K950043 is an FDA 510(k) premarket notification submitted by Jpi Healthcare Co, Ltd. for the device "JPI AUTOMATIC X-RAY FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on May 10, 1995. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Jpi Healthcare Co, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
January 5, 1995
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 Jpi Healthcare Co, Ltd.

  • K260482 — DRE Duo (June 15, 2026)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K213057 — ExamVue Duo (February 18, 2022)
  • K142930 — Exam Vue DR (April 17, 2015)
  • K102327 — CLEARVISION DR 7000F (April 13, 2012)
  • K101779 — CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (May 16, 2011)
  • K955706 — JPI AUTOMATIC X-RAY FILM PROCESSOR (February 12, 1996)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)

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