FDA product code OUO: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OUO is the FDA product code for tomographic imager combining emission computed tomography with nuclear magnetic resonance. It is a Class II device, regulated under 21 CFR 892.1200 and reviewed by the Radiology panel. FDA has cleared 15 510(k) submissions under OUO, 5 in the last five years, from 6 different applicants. The average 510(k) review took 123 days (median 104); 158 days on average over the last three years. FDA has posted 9 recalls for OUO devices, 3 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device class | Class II |
| Regulation | 21 CFR 892.1200 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for OUO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 80 |
| 2019 | 2 | 87 |
| 2020 | 1 | 104 |
| 2022 | 2 | 70 |
| 2024 | 1 | 147 |
| 2026 | 2 | 168 |
Compare with all 510(k) review times · Search every OUO clearance
Top OUO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 5 | 2020-05-11 |
| Shanghai United Imaging Healthcare Co., Ltd. | 4 | 2024-05-24 |
| Ge Medical Systems, LLC | 3 | 2022-01-20 |
| Cubresa, Inc. | 1 | 2026-07-17 |
| Siemens Healthineers AG | 1 | 2026-01-15 |
1 more applicants have OUO clearances. See the full list in Caduvo.
Most recent OUO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253963 | Cubresa, Inc. | Cubresa BrainPET | 2026-07-17 | 218 |
| K253023 | Siemens Healthineers AG | BIOGRAPH One | 2026-01-15 | 118 |
| K234154 | Shanghai United Imaging Healthcare Co., Ltd. | uPMR 790 | 2024-05-24 | 147 |
| K222540 | Shanghai United Imaging Healthcare Co., Ltd. | uPMR 790 | 2022-11-14 | 84 |
| K213709 | Ge Medical Systems, LLC | SIGNA PET/MR | 2022-01-20 | 57 |
Recalls for OUO devices
9 product recalls in 9 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-08-28.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code OUO?
OUO is the FDA product code for tomographic imager combining emission computed tomography with nuclear magnetic resonance. It is a Class II device, regulated under 21 CFR 892.1200 and reviewed by the Radiology panel.
What device class is OUO?
Class II, regulation 21 CFR 892.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUO?
Across 15 cleared submissions the average was 123 days from receipt to decision (median 104).
Which companies have the most OUO clearances?
Siemens Medical Solutions USA, Inc. (5); Shanghai United Imaging Healthcare Co., Ltd. (4); Ge Medical Systems, LLC (3); Cubresa, Inc. (1); Siemens Healthineers AG (1).
Have OUO devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2025-08-28.
Next steps
- Run an FDA pathway report with predicate devices for product code OUO
- Run a recall and safety report across every OUO manufacturer
- Watch product code OUO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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