510(k) K945858

X-RAY FILM CASSETTE by J.P.I. Chicago Co. — Product Code IXA

K945858 is an FDA 510(k) premarket notification submitted by J.P.I. Chicago Co. for the device "X-RAY FILM CASSETTE". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. J.P.I. Chicago Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
December 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