# K173816: NM/CT 850, NM/CT 860 - Pathway: 510(k) (Traditional) - Applicant: GE Healthcare - Decided: Apr 17, 2018 after 123 days - Product code: KPS (System, Tomography, Computed, Emission) - Device class: 2 - Regulation: 21 CFR 892.1200 - Recalls of this device: 10 (1 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 8 generations back to K952674 (1995). 31 ancestors in all. No later device cites it as a predicate yet. 6 of 32 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K093514: Discovery Model NM/CT 670, Ge Medical Systems F.I. Haifa (2009) Summary page 7. ## Recalls of this device - Dec 19, 2022 · Class I · Z-1058-2023: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. - Feb 7, 2021 · Class II · Z-1546-2021: GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range - Feb 7, 2021 · Class II · Z-1545-2021: GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range - Dec 10, 2020 · Class II · Z-0854-2021: GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. - Dec 10, 2020 · Class II · Z-0853-2021: GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. - Aug 14, 2020 · Class II · Z-2992-2020: Rotor bearing screws were found loose on detector. - Aug 14, 2020 · Class II · Z-2991-2020: Rotor bearing screws were found loose on detector. - Mar 20, 2019 · Class II · Z-1263-2019: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector moun - Mar 20, 2019 · Class II · Z-1262-2019: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector moun - Mar 20, 2019 · Class II · Z-1261-2019: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector moun ## Indications for use The GE NM/CT 850 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy. NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). Imaging modes include single photon, multi-isotope, and multi peak frame, with data stored frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Intended specifically for attenuation correction and anatomical localization. NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion). The GE NM/CT 850 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results, and uptake quantitation. The system may be used for patients of all ages. NM/CT 850 does not support standalone CT operation. The GE NM/CT 860 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy. NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine and Helical acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion). The GE NM/CT 860 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes., The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages. Source page: https://510kreport.com/device/K173816 Methodology: https://510kreport.com/methodology