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

Dosimeter, Ionizing Radiation, Implanted

21 CFR 892.5050 / Radiology
FDA source (opens on fda.gov)

NZT is the FDA product code for Dosimeter, Ionizing Radiation, Implanted, a class II device type, regulated under 21 CFR 892.5050. FDA's definition for this code reads: "Verify radiation dose to organs from external radiation therapy". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
NZT
Device name
Dosimeter, Ionizing Radiation, Implanted
FDA definition
Verify radiation dose to organs from external radiation therapy.
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
5

Clearances, product code NZT

By decision year
7 clearances under product code NZT with a decision year between 2008 and 2025, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NZT by decision year
YearClearances
20082
20141
20151
20171
20191
20251

Applicants with the most clearances

Product code NZT
Applicants holding the most 510(k) clearances under product code NZT
ApplicantClearances
Radiadyne3
Sicel Technologies, Inc.2
Nu-Rise, SA1
Radialdyne, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

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