# Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OUO)
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