DeviceClearance

Product code MQB— Radiology

SKR 3000

Classification name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Total cleared
424
First cleared
Most recent

Market context for product code MQB

FDA has cleared 424 devices under product code MQB between 1997 and 2026, filed by 130 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 MQB

Recent clearances under product code MQB

1–100 of 424

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