510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KPXClass II

Changer, Radiographic Film/Cassette

21 CFR 892.1860 / Radiology
FDA source (opens on fda.gov)

KPX is the FDA product code for Changer, Radiographic Film/Cassette, a class II device type, regulated under 21 CFR 892.1860. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KPX
Device name
Changer, Radiographic Film/Cassette
Regulation
21 CFR 892.1860
Device class
Class II
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
0

Clearances, product code KPX

By decision year
26 clearances under product code KPX with a decision year between 1976 and 1995, 1993 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KPX by decision year
YearClearances
19761
19771
19792
19802
19812
19821
19841
19852
19861
19871
19902
19911
19923
19934
19941
19951

Applicants with the most clearances

Product code KPX
Applicants holding the most 510(k) clearances under product code KPX
ApplicantClearances
Canon Medical Components U.S.A., Inc.5
Mallinckrodt Group, Inc.4
B C Medical, Ltd.2
Elema-Schonander, Inc.2
Acoma Medical Imaging, Inc.1
Burbury & Cutter Ind., Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Memco, Inc.1
Midwest X-Ray Equipment Co.1
Philips North America LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KPX.