# K131576: Optima CT660

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 30, 2013 after 91 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K013561 (2001). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110227: Optima CT660, Ge Medical Systems, LLC (2011) Summary page 2.

## Most influential descendants
- K192686: Revolution Maxima, Revolution Ace (2019), 4 descendants of its own
- K203169: Revolution Ascend (2020), 3 descendants of its own
- K213938: Revolution Ascend (2022), 2 descendants of its own
- K233698: True Enhance DL (2024), 0 descendants of its own
- K233749: Revolution Ascend Sliding (2024), 0 descendants of its own

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0608-2025: GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly
- Jun 14, 2021 · Class II · Z-1900-2021: Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
- May 24, 2018 · Class II · Z-2584-2018: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- May 24, 2018 · Class II · Z-2583-2018: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- Apr 27, 2018 · Class II · Z-2873-2018: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
- Apr 27, 2018 · Class II · Z-2870-2018: GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
- May 19, 2017 · Class II · Z-2181-2017: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- May 19, 2017 · Class II · Z-2182-2017: 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 Optima CT660 is intended to produce crass-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Source page: https://510kreport.com/device/K131576
Methodology: https://510kreport.com/methodology