510(k) · Cleared
Recalled · Class II · 2012Biograph MMR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Cleared on Jun 8, 2011 as substantially equivalent to K072237 (Siemens Medical Solutions USA, Inc., 2007) and 2 other predicates after a 198-day review. Its family tree reaches back 9 generations to 2000. 2 of the 48 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled once.
- Decided
- Jun 8, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- OUO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K002715 (2000). 26 ancestors in all, the oldest K843696 (1985). 21 later devices descend from it, 1 citing it directly. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 2 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- This deviceK103429 Biograph MMRSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 20 of its ownK133226 Biograph MMRSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 12 of its ownK163234 Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK173635 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 4 generations on · 6 of its ownK192065 Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 6 of its ownK142098 Signa Pet/MRGe Medical Systems, LLC · 2014 · Recalled
Show all 9 generations
- Root · 9 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 8 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 7 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 6 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 5 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 4 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 3 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 2 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- This deviceK103429 Biograph MMRSiemens Medical Solutions USA, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K133226Biograph MMRSiemens Medical Solutions USA, Inc. · 2013 · cites it directly20descendants
- K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. · 2017 · 2 generations on12descendants
- K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on7descendants
- K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · 4 generations on6descendants
- K142098Signa Pet/MRGe Medical Systems, LLC · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −8 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −7 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −6 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −5 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −4 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −3 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −2 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −1 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| 0 (this device) | K103429 | Biograph MMR | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K133226 | Biograph MMR | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| +2 | K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +3 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +4 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2019 | 2 |
| +2 | K142098 | Signa Pet/MR | Ge Medical Systems, LLC | 2014 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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.
2 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072237 | Magnetom VerioSummary page 2…uivalence isclaimed Device Manufacturer 510(k) Number MAGNETOM \/erio Siemens AG K(072237 MR BI 7 Software Siemens AG K082427 Update Biograph mCT.X and Siemens Medic… | 2007 |
| * | K082427 | Syngo MR B17Summary page 2…510(k) Number MAGNETOM \/erio Siemens AG K(072237 MR BI 7 Software Siemens AG K082427 Update Biograph mCT.X and Siemens Medical Solutions USA, K1~0550 and K081453 mCT*S (Biograph HD) In… | 2008 |
| Kept off the family tree | K100550 | FDA’s K100550 is Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K081453 | Biograph HD FamilySummary page 2…K(072237 MR BI 7 Software Siemens AG K082427 Update Biograph mCT.X and Siemens Medical Solutions USA, K1~0550 and K081453 mCT*S (Biograph HD) Inc. Device Description: The Biograph mMR systems are combined Magnetic Resonance Diagnostic… | 2008 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133226 | Biograph MMR | 2013 | 20 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2012 | Class II | Z-2464-2012 | Device Design | When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the… |
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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 15 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133226 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 20 descendants of its own.
- 8 other devices also cite its predicate K072237.
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. 2011, 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 Siemens MR-PET 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 isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by…
Read the full statement (242 words)
The Siemens MR-PET 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 isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.
The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR-images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR-safe biopsy needles.
The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
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/K103429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103429: Biograph MMR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103429
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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