Last synced on 14 June 2024 at 11:05 pm

Radiation Therapy Marking Device

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5785
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRN is linked to regulation 21CFR892.5785, which does not seem to exist yet. It may be pending at the moment.

Radiation Therapy Marking Device

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5785
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QRN is linked to regulation 21CFR892.5785, which does not seem to exist yet. It may be pending at the moment.