# K210760: Precise Image

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 14, 2022 after 305 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930090 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180015: Philips Incisive CT, Philips Healthcare (Suzhou) Co., Ltd. (2018) Summary page 4.

## Indications for use
The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. Precise Image has been evaluated and available on preselected reference protocols for adult subjects. Precise Image is not indicated for use in pediatric subjects. The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging. Precise Image uses an Artificial Intelligence powered reconstruction algorithm that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.

Source page: https://510kreport.com/device/K210760
Methodology: https://510kreport.com/methodology