# K253560: Enhanced Boundary for PCCT

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 24, 2026 after 219 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: 10 generations back to K013561 (2001). 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)
- K213715: Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition, Ge Medical Systems, LLC (2021) Summary page 5.

## Indications for use
Enhanced Boundary for PCCT is a deep learning-based CT processing method used for improved soft tissue delineation in routine head exams with and without contrast. Enhanced Boundary for PCCT may be used for patients of all ages.

Source page: https://510kreport.com/device/K253560
Methodology: https://510kreport.com/methodology