# K001088: Ultrasim CT System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 22, 2000 after 79 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033357: Acqsim-Multislice-CT, Model 453567042271 (2004), 10 descendants of its own
- K171850: Philips CT Big Bore (2017), 6 descendants of its own
- K240844: Spectral CT 7500 RT (2024), 3 descendants of its own
- K181797: Philips CT Big Bore Sliding Gantry Configuration (2018), 1 descendant of its own
- K160611: P-Artis (2016), 1 descendant of its own

## Recalls of this device
- May 1, 2021 · Class II · Z-0277-2022: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, b
- Mar 23, 2004 · Not classified · Z-0958-05: Software anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.

Source page: https://510kreport.com/device/K001088
Methodology: https://510kreport.com/methodology