# K210173: StarGuide

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 29, 2021 after 66 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K952674 (1995). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153402: Discovery NM/CT 670 CZT, GE Healthcare (2016) Summary page 6.

## Most influential descendants
- K241350: Clarify DL (2025), 0 descendants of its own

## Indications for use
The GE StarGuide 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, orthopedic disorders, and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures. The GE StarGuide 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 tomographic scanning of single or multi-isotopes with either single or multi energy peaks. The tomographic scanning is supported by various acquisition types and by imaging features designed to enhance image quality. • 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 corrections of SPECT images as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE StarGuide system includes digital processing of data and images, signal analysis and display equipment, patient and equipment supports, components and accessories. 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. FAME: Functional-Anatomical Mutual Enhancement (FAME) technology is an image processing method intended for Computed Tomography (CT) based corrections of Nuclear Medicine (NM) bone scintigraphy images. FAME adjusts the radioisotope tracer distribution to correlate with the skeletal anatomical structures in the CT image. FAME may be used for patients of all ages.

Source page: https://510kreport.com/device/K210173
Methodology: https://510kreport.com/methodology