# K253670: SmartCT (R3.0 (L10))

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems B.V.
- Decided: Jul 10, 2026 after 231 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K913770 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201583: SmartCT R1.0, Philips Medical Systems Nederland B.V. (2021) Summary page 6.

## Indications for use
SmartCT assists physicians during vascular and non-vascular procedures, with diagnosis, treatment planning, interventional procedures and treatment follow-up by creating 3D views from sets of 2D images created during rotational acquisitions. SmartCT provides high-speed and high-resolution 3D visualizations of vasculature, hemorrhages, soft tissue and bone structures. SmartCT provides live image guidance for navigating endovascular devices through vascular structures anywhere in the body. SmartCT helps to assess anatomical information intra-procedurally, such as the estimate of a vessel or lesion size, diameter or volume, and anatomical distances between relevant structures. SmartCT is intended to be used for human patients that have been elected for the procedures as described in these Indications for Use.

Source page: https://510kreport.com/device/K253670
Methodology: https://510kreport.com/methodology