DeviceClearance

Product code KPS— Radiology

uMI Panorama

Classification name
System, Tomography, Computed, Emission
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Total cleared
473
First cleared
Most recent

Market context for product code KPS

FDA has cleared 473 devices under product code KPS between 1977 and 2026, filed by 131 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 KPS

Recent clearances under product code KPS

1–100 of 473

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