DeviceClearance

Product code KQA— Radiology

COLLIMATOR, BILATERIAL

Classification name
Device, Beam Limiting, X-Ray, Therapeutic
Device class
Class 2
Regulation
21 CFR 892.5900
Advisory panel
Radiology
Total cleared
4
First cleared
Most recent

Market context for product code KQA

FDA has cleared 4 devices under product code KQA between 1979 and 1992, filed by 4 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

Top applicants under product code KQA

Recent clearances under product code KQA

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