Radiation Therapy Marking Device
The Radiation Therapy Marking Device is a powered device that transdermally delivers permanent or temporary colorant to the skin to place precision marks used as reference points for guiding radiation therapy treatments. The device uses a needle-based mechanism to deposit the colorant and is distinct from devices intended for diagnostic, therapeutic, or cosmetic tattooing. Classified as FDA Class 2 under regulation 892.5785, it requires 510(k) clearance and is reviewed under the Radiology specialty. It excludes devices with reusable or reprocessed needles and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- QRN
- Device Class
- FDA class 2
- Regulation Number
- 892.5785
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.