# K153402: Discovery NM/CT 670 CZT

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jan 21, 2016 after 58 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 6 (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.
6 later devices descend from it; 2 cite it directly.
6 of 38 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 8.

## Most influential descendants
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K190457: VERITON CT whole body SPECT/CT system (2019), 2 descendants of its own
- K230600: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (2023), 1 descendant of its own
- K210173: StarGuide (2021), 1 descendant of its own
- K254001: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (2026), 0 descendants of its own

## Recalls of this device
- Dec 19, 2022 · Class I · Z-1057-2023: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
- Dec 10, 2020 · Class II · Z-0855-2021: 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-2993-2020: Rotor bearing screws were found loose on detector.
- Mar 20, 2019 · Class II · Z-1258-2019: 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-1264-2019: 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
- May 19, 2017 · Class II · Z-2195-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

## Indications for use
The GE Discovery NM/CT 670 CZT system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and 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, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 CZT system, combining a CZT-based, high energy and spatial resolution, Nuclear Medicine (NM) system and a Computed Tomography (CT) system, is intended to produce: • 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 scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include, gating by physiological signals, and real-time automatic body contouring. • CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac 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 Discovery NM/CT 670 CZT system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image 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/K153402
Methodology: https://510kreport.com/methodology