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

Generator, High Voltage, X-Ray, Therapeutic

21 CFR 892.5900 / Radiology
FDA source (opens on fda.gov)

KPZ is the FDA product code for Generator, High Voltage, X-Ray, Therapeutic, a class II device type, regulated under 21 CFR 892.5900. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KPZ
Device name
Generator, High Voltage, X-Ray, Therapeutic
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code KPZ

By decision year
3 clearances under product code KPZ with a decision year between 1986 and 1991, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KPZ by decision year
YearClearances
19862
19911

Applicants with the most clearances

Product code KPZ
Applicants holding the most 510(k) clearances under product code KPZ
ApplicantClearances
Old Delft Corp. of America1
Theta Systems, Inc.1
Victoreen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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