JPI AUTOMATIC X-RAY FILM PROCESSOR— 510(k) K950043

Name: FDA 510(k) clearance K950043
Creator: U.S. Food and Drug Administration
Published: 1995-05-10

Substantially Equivalent

Jpi Healthcare Co, Ltd.

FDA 510(k) clearance K950043 for JPI AUTOMATIC X-RAY FILM PROCESSOR, Substantially Equivalent on 1995-05-10. Applicant: Jpi Healthcare Co, Ltd.. Device class: 2.

Clearance details

Applicant: Jpi Healthcare Co, Ltd.
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1995-01-05
Decision date: 1995-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayside, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IXW

view all

K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT2011-08-18
K093503 — INTRAX FILM PROCESSOR2010-01-06
K091628 — OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX2009-08-21
K024342 — RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP10002003-04-23
K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 10002003-02-12

More clearances from Jpi Healthcare Co, Ltd.

view all

K260482 — DRE Duo2026-06-15
K244010 — ExamVue Apex2025-02-24
K213057 — ExamVue Duo2022-02-18
K142930 — Exam Vue DR2015-04-17
K102327 — CLEARVISION DR 7000F2012-04-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.