Home / 510(k) Clearances / K954161

510(k) K954161

JPI INTENSIFYING SCREEN by Jpi Healthcare Co, Ltd. — Product Code EAM

K954161 is an FDA 510(k) premarket notification submitted by Jpi Healthcare Co, Ltd. for the device "JPI INTENSIFYING SCREEN". The FDA issued a decision of Substantially Equivalent on February 2, 1996. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Jpi Healthcare Co, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1996
Date Received
September 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Intensifying, Radiographic
Device Class
Class I
Regulation Number
892.1960
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)
  • K950043 — JPI AUTOMATIC X-RAY FILM PROCESSOR (May 10, 1995)

Other clearances for product code EAM

  • K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (December 22, 1997)
  • K963913 — MD100 & MM150 (October 8, 1997)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (August 22, 1994)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942399 — KYOKKO UM SERIES INTENSIFYING SCREEN (June 10, 1994)

FDA data resources