# K203514: Precise Position

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Jun 17, 2021 after 199 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 Position is intended for use with Philips Incisive CT systems. The device provides the following guided workflow. • Patient orientation identification • Surview range recommendation • Automatic centering the patient anatomy • Provide visual images of patient on the table Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies. Patient population limitation: Patient younger than 16 years are not supported.

Source page: https://510kreport.com/device/K203514
Methodology: https://510kreport.com/methodology