FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

JPI X-RAY GRID

K Number: K945327 · Decision Jan 20, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
14
Applicant Total
3
Review Days
80

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Basic Information

Device Name
JPI X-RAY GRID
K Number
K945327
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1910
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Jpi America, Inc.
Date Received
November 1, 1994
Decision Date
January 20, 1995
Product Code
IXJ
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IXJ Grid, Radiographic

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Other Clearances by Jpi America, Inc.

K Number Device Name
K052341 AJEX 9015/135H PORTABLE X-RAY
K945328 JPI X-RAY FILM CASSETTE