DeviceClearance

Product code NQQ— Radiology

ILUMIEN OPTIS

Classification name
System, Imaging, Optical Coherence Tomography (Oct)
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Total cleared
46
First cleared
Most recent

FDA classification definition

“This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.”

— U.S. Food and Drug Administration, device classification record for product code NQQ under 21 CFR 892.1560, via openFDA

Market context for product code NQQ

FDA has cleared 46 devices under product code NQQ between 2004 and 2026, filed by 21 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 NQQ

Recent clearances under product code NQQ

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