Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

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

Classification

FDA Product Code: OUO
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

Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.

Market data

Cleared 510(k) submissions: 14
Registered establishments: 11

Source

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