IZTClass II

Cone, Radiographic

21 CFR 892.1610 / Radiology

IZT is the FDA product code for Cone, Radiographic, a class II device type, regulated under 21 CFR 892.1610. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1992-12-09, and no recalls.

Classification record

Product code: IZT
Device name: Cone, Radiographic
Regulation: 21 CFR 892.1610
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: 1
Ingested recalls: 0

Clearances, product code IZT

By decision year

1 clearance under product code IZT with a decision year between 1992 and 1992, 1992 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code IZT by decision year
Year	Clearances
1992	1

Applicants with the most clearances

Product code IZT

Applicants holding the most 510(k) clearances under product code IZT
Applicant	Clearances
Denar Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code IZT

K924759Class IICollimator Light SourceDenar Corp. / cleared 1992-12-09

Recent recalls

Product code IZT

FDA records show no recalls under product code IZT.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)