QRNClass II
Radiation Therapy Marking Device
21 CFR 892.5785 / Radiology
QRN is the FDA product code for Radiation Therapy Marking Device, a class II device type, regulated under 21 CFR 892.5785. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QRN
- Device name
- Radiation Therapy Marking Device
- FDA 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.
- Regulation
- 21 CFR 892.5785
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QRN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code QRN| Applicant | Clearances |
|---|---|
| Medical Precision BV | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.