510(k) · Cleared
Recalled · Class II · 2025Signa Pet/MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Cleared on Jan 20, 2022 as substantially equivalent to K163619 (Ge Medical Systems, LLC, 2017) after a 57-day review. Its family tree reaches back 14 generations to 1997. 3 of the 53 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times.
- Decided
- Jan 20, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- OUO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 14 generations to K971684 (1997). 52 ancestors in all, the oldest K843696 (1985). No later device cites it as a predicate yet. 3 of the 53 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations between
- 3 generations backK133226 Biograph MMRSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK142098 Signa Pet/MRGe Medical Systems, LLC · 2014 · Recalled
- 1 generation backK163619 Signa Pet/MRGe Medical Systems, LLC · 2017 · Recalled
- This deviceK213709 Signa Pet/MRGe Medical Systems, LLC · 2022
Show all 14 generations
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 13 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 12 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 10 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 9 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 8 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 7 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 6 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 5 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 4 generations backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- 3 generations backK133226 Biograph MMRSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK142098 Signa Pet/MRGe Medical Systems, LLC · 2014 · Recalled
- 1 generation backK163619 Signa Pet/MRGe Medical Systems, LLC · 2017 · Recalled
- This deviceK213709 Signa Pet/MRGe Medical Systems, LLC · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −13 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −12 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −11 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −10 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −9 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −8 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −7 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −6 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −5 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −4 | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR… | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −3 | K133226 | Biograph MMR | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| −2 | K142098 | Signa Pet/MR | Ge Medical Systems, LLC | 2014 | 6 |
| −1 | K163619 | Signa Pet/MR | Ge Medical Systems, LLC | 2017 | 7 |
| 0 (this device) | K213709 | Signa Pet/MR | Ge Medical Systems, LLC | 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 |
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 |
|---|---|---|---|
| * | K163619 | Signa Pet/MRSummary page 4…892.1200 Product Code: OUO Predicate Device(s): SIGNA PET/MR (K163619) Device Description: The GE SIGNA PET/MR system is a combined Magnetic… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2025 | Class II | Z-2309-2025 | Equipment maintenance | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA… |
| Oct 28, 2024 | Class II | Z-0520-2025 | Device Design | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
| Jun 14, 2024 | Class II | Z-2466-2024 | Device Design | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2… |
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 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 7 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 26 of the 52 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. 2022, 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 SIGNA PET/MR 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 SIGNA PET/MR 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. 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.
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/K213709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213709: Signa Pet/MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213709
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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