QRN — Radiation Therapy Marking Device Class II
FDA product code QRN covers "Radiation Therapy Marking Device", a Class II medical device regulated under 21 CFR 892.5785. Submissions are reviewed by the Radiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QRN
- Device Class
- Class II
- Regulation Number
- 892.5785
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.