DeviceClearance

Product code NFJ— Radiology

CALLISTO eye

Classification name
System, Image Management, Ophthalmic
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
53
First cleared
Most recent

Market context for product code NFJ

FDA has cleared 53 devices under product code NFJ between 2002 and 2026, filed by 33 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 NFJ

Recent clearances under product code NFJ

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