Cabinet, Emission Computed Tomography System

QXL · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1200

Classification

FDA Product Code: QXL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.1200
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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