510(k) · Cleared
CleareduPMR 790
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Cleared on May 24, 2024 as substantially equivalent to K222540 (Shanghai United Imaging Healthcare Co., Ltd., 2022) after a 147-day review. Its family tree reaches back 16 generations to 1997. 3 of the 55 devices in its family, counting itself, have a Class I recall.
- Decided
- May 24, 2024
- Review
- 147 days
- Class
- Class II
- Product code
- OUO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K971684 (1997). 54 ancestors in all, the oldest K843696 (1985). No later device cites it as a predicate yet. 3 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 12 generations between
- 3 generations backK183014 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- 2 generations backK192672 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- 1 generation backK222540 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2022
- This deviceK234154 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2024
Show all 16 generations
- Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 15 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 14 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 12 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 11 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 10 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 9 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 8 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 7 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 6 generations backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- 5 generations backK133226 Biograph MMRSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 4 generations backK142098 Signa Pet/MRGe Medical Systems, LLC · 2014 · Recalled
- 3 generations backK183014 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- 2 generations backK192672 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- 1 generation backK222540 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2022
- This deviceK234154 uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −15 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −14 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −13 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −12 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −11 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −10 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −9 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −8 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −7 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −6 | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR… | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −5 | K133226 | Biograph MMR | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| −4 | K142098 | Signa Pet/MR | Ge Medical Systems, LLC | 2014 | 6 |
| −3 | K183014 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| −2 | K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| −1 | K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2022 | — |
| 0 (this device) | K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OUO device
- #1 K253963 Cubresa BrainPETscore 15.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222540 | uPMR 790Summary page 4…latory Class: II Product Code: OUO, MOS Review Panel: Radiology 4. Identification of Primary/Reference Device(s) Predicate Device 510(k) Number: K222540 Device Name: uPMR 790 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code:… | 2022 |
| † | K220332 | uMR Omega with uWS-MR-MRS | 2022 |
| † | K230152 | uMR Omega | 2023 |
| † | K210001 | HYPER AiR | 2021 |
| † | K193241 | Emission Computed Tomography System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 7 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 9 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 25 of the 54 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All OUO devicesOUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OUO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OUO
84in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUO
1in 2021
MAUDE reports naming product code OUO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 1 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 84 | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal…
Read the full statement (157 words)
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234154: uPMR 790.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026