DeviceClearance

Product code IZF— Radiology

Nanox.ARC

Classification name
System, X-Ray, Tomographic
Device class
Class 2
Regulation
21 CFR 892.1740
Advisory panel
Radiology
Total cleared
42
First cleared
Most recent

Market context for product code IZF

FDA has cleared 42 devices under product code IZF between 1976 and 2026, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code IZF

Recent clearances under product code IZF

Data sourced from openFDA. This site is unofficial and independent of the FDA.