QRN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Radiation Therapy Marking Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5785
- Medical specialty
- Radiology
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Comfort Marker 2.0 (K222112) | Medical Precision BV | 2023-03-30 |
| Comfort Marker 2.0. (DEN200041) | Medical Precision BV | 2021-12-10 |
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Every clearance here is in the API, with alerts when new ones post.