Device class
Class II
Regulation 892.1200
Total clearances
6
2020-05-11 → 2026-07-17
Definition
What is Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
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.
Classification details
Medical specialty
Radiology
Regulation number
892.1200
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 78815 |
CPT
|
— |
High
|
PET-CT imaging; OUO is PET/MR hybrid tomographic imager with attenuation correction |
| 78814 |
CPT
|
— |
Medium
|
PET imaging whole body; alternative PET code depending on protocol |
Pulse
Most recent 510(k) clearances