510(k) · Cleared
ClearedBiograph mMR with syngo MR E11P system software
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 Feb 28, 2017 as substantially equivalent to K133226 (Siemens Medical Solutions USA, Inc., 2013) and 2 other predicates after a 103-day review. Its family tree reaches back 13 generations to 1997. 6 of the 66 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Feb 28, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- OUO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K971684 (1997). 53 ancestors in all, the oldest K843696 (1985). 12 later devices descend from it, 4 citing it directly. 6 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations between
- 3 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 2 generations backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- 1 generation backK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- This deviceK163234 Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK173635 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK192065 Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 5 of its ownK201444 Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 4 generations on · 4 of its ownK211379 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 5 generations on · 3 of its ownK220783 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 12 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 11 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 9 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 8 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 7 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 6 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 5 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 4 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 3 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 2 generations backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- 1 generation backK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- This deviceK163234 Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma…direct predicate · 2016
- K121434 Software Syngo MR D13A for the Magnetom Systems…direct predicate · 2012
- K151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit…2 generations back · 2015
- K101347 Magnetom Aera; Magnetom Skyra3 generations back · 2010
Most influential descendants
Showing 5 of 12 · See all- K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018 · cites it directly7descendants
- K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · 2 generations on6descendants
- K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on5descendants
- K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · 4 generations on4descendants
- K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −12 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −11 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −10 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −9 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −8 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −7 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −6 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −5 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −4 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −3 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −2 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| −1 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | Class I |
| 0 (this device) | K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +1 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2019 | 2 |
| +3 | K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +4 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2021 | 2 |
| +5 | K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2022 | — |
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 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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.
6 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? (3)
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 |
|---|---|---|---|
| * | K133226 | Biograph MMRSummary page 8…gical Characteristics Software syngo MR E11P for Biograph mMR has the same technological characteristics as the primary predicate device Biograph mMR with syngo MR B20P (K133226, cleared November 12, 2013). The subject device is substantially equivalent to the predicate devices with regard to the operation… | 2013 |
| * | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSummary page 8…ence control and image reconstruction without additional MRIR. The introduction of the MaRS was part of the secondary predicate device MAGNETOM Verio with syngo MR D13A (K121434). This is now updated to new computer hardware with this submission. Physiological Monitoring Unit (PMU) The Physiological Measur… | 2012 |
| * | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSummary page 6…nd features from the previously cleared secondary predicate devices MAGNETOM Verio with syngo MR D13A and Siemens E-line Software with MAGNETOM Skyra with syngo MR E11C (K153343) are not described separately as these are commercially available and no changes are introduced for this system. Improvement in… | 2016 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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.
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 26 of the 53 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K173635 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K133226.
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. 2017, 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 (244 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 crosssectional 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/K163234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163234: Biograph mMR with syngo MR E11P system software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163234
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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