Product code QRN
- Device name
- Radiation Therapy Marking Device
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5785
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K222112 | Comfort Marker 2.0 | Medical Precision BV | 2023-03-30 |
| DEN200041 | Comfort Marker 2.0. | Medical Precision BV | 2021-12-10 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 08720165025022 | Medical Precision Comfort Marker | Medical Precision B.V. | 2026-03-12 |
| 08720165025039 | Medical Precision Comfort Marker | Medical Precision B.V. | 2026-03-12 |
| 78720165025007 | Medical Precision Comfort Marker | Medical Precision B.V. | 2026-03-11 |
| 78720165025014 | Medical Precision Comfort Marker | Medical Precision B.V. | 2026-03-11 |
| 08720165025046 | Medical Precision Comfort Marker | Medical Precision B.V. | 2026-03-11 |
| 08720165025053 | Medical Precision Comfort Marker | Medical Precision B.V. | 2026-03-11 |