# K133134: X-Porte Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Nov 4, 2013 after 34 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K131156: Lanx Spinal Fixation System, Lanx, Inc. (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K142017: X-Porte Ultrasound System (2014), 46 descendants of its own
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System (2015), 45 descendants of its own
- K153626: SonoSite Edge II Ultrasound System (2016), 42 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own
- K172385: Clarius Ultrasound System (2017), 22 descendants of its own

## Indications for use
The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel

Source page: https://510kreport.com/device/K133134
Methodology: https://510kreport.com/methodology