Radiation Therapy Marking Device

QRN · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5785

Classification

FDA Product Code: QRN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.5785
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown