FDA product code QRN: Radiation Therapy Marking Device
QRN is the FDA product code for radiation therapy marking device. It is a Class II device, regulated under 21 CFR 892.5785 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under QRN, 1 in the last five years. The average 510(k) review took 255 days (median 255). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Radiation Therapy Marking Device |
| Device class | Class II |
| Regulation | 21 CFR 892.5785 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QRN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 255 |
Compare with all 510(k) review times · Search every QRN clearance
Top QRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Precision BV | 1 | 2023-03-30 |
Most recent QRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222112 | Medical Precision BV | Comfort Marker 2.0 | 2023-03-30 | 255 |
Recalls for QRN devices
openFDA lists no recalls for product code QRN.
Frequently asked questions
What is FDA product code QRN?
QRN is the FDA product code for radiation therapy marking device. It is a Class II device, regulated under 21 CFR 892.5785 and reviewed by the Radiology panel.
What device class is QRN?
Class II, regulation 21 CFR 892.5785. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRN?
Across 1 cleared submissions the average was 255 days from receipt to decision (median 255).
Which companies have the most QRN clearances?
Medical Precision BV (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QRN
- Run a recall and safety report across every QRN manufacturer
- Watch product code QRN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times