Home / 510(k) Clearances / K945328

510(k) K945328

JPI X-RAY FILM CASSETTE by Jpi America, Inc. — Product Code IXA

K945328 is an FDA 510(k) premarket notification submitted by Jpi America, Inc. for the device "JPI X-RAY FILM CASSETTE". The FDA issued a decision of Substantially Equivalent on January 20, 1995. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Jpi America, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1995
Date Received
November 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

Other clearances by Jpi America, Inc.

  • K052341 — AJEX 9015/135H PORTABLE X-RAY (October 7, 2005)
  • K945327 — JPI X-RAY GRID (January 20, 1995)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K053173 — DS CASSETTE (December 15, 2005)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (July 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (October 12, 2001)
  • K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (August 9, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)

FDA data resources