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U.S. Department of Health and Human Services

Product Classification
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Device radiation therapy marking device
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.
Physical State Powered delivery device with single use needle cartridge and multi-use motorized base.
Technical Method The skin is mechanically punctured to deliver colorant transdermally.
Target Area Skin.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQRN
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5785
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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