QRN · Class II · 21 CFR 892.5785

FDA Product Code QRN: Radiation Therapy Marking Device

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.

Leading manufacturers include Medical Precision BV.

2
Total
1
Cleared
396d
Avg days
2021
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Radiation Therapy Marking Device Devices (Product Code QRN)

2 devices
1–2 of 2
Cleared Mar 30, 2023
Comfort Marker 2.0
K222112
Medical Precision BV
Radiology · 255d
Not Cleared Dec 10, 2021
Comfort Marker 2.0.
DEN200041
Medical Precision BV
Radiology · 536d

About Product Code QRN - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QRN since 2021, with 1 receiving FDA clearance (average review time: 396 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QRN devices are reviewed by the Radiology panel. Browse all Radiology devices →