# K142098: Signa Pet/MR

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Nov 24, 2014 after 115 days
- Product code: OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K971684 (1997). 50 ancestors in all.
6 later devices descend from it; 2 cite it directly.
3 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133226: Biograph MMR, Siemens Medical Solutions USA, Inc. (2013) Summary page 4.

## Most influential descendants
- K183014: uPMR 790 (2019), 3 descendants of its own
- K192672: uPMR 790 (2019), 2 descendants of its own
- K222540: uPMR 790 (2022), 1 descendant of its own
- K163619: Signa Pet/MR (2017), 1 descendant of its own
- K234154: uPMR 790 (2024), 0 descendants of its own

## Recalls of this device
- Jun 20, 2025 · Class II · Z-2309-2025: 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, Disc
- Oct 28, 2024 · Class II · Z-0520-2025: 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: 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
- Dec 23, 2021 · Class II · Z-0595-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- May 11, 2017 · Class II · Z-3029-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Aug 31, 2015 · Class II · Z-0260-2016: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling sugge

## Indications for use
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.

Source page: https://510kreport.com/device/K142098
Methodology: https://510kreport.com/methodology