DeviceClearance

Product code QRN— Radiology

Comfort Marker 2.0

Classification name
Radiation Therapy Marking Device
Device class
Class 2
Regulation
21 CFR 892.5785
Advisory panel
Radiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses.”

— U.S. Food and Drug Administration, device classification record for product code QRN under 21 CFR 892.5785, via openFDA

Market context for product code QRN

FDA has cleared 2 devices under product code QRN between 2021 and 2023, filed by 1 applicant company. 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 QRN

Recent clearances under product code QRN

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