# K191136: Access CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Jul 29, 2019 after 91 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: 5 generations back to K930090 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091195: Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511, Philips Medical Systems (Cleveland), Inc. (2009) Summary page 4.

## Indications for use
The Access CT scanner system can be used as a Whole Body (except cardiac) Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multislice capability up to 6/16 slices simultaneously. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.

Source page: https://510kreport.com/device/K191136
Methodology: https://510kreport.com/methodology