# K103629: Pet-512MC Transesophageal Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Feb 2, 2011 after 51 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894632 (1989). 113 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092179: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001, Toshiba America Medical Systems, In.C (2009) Summary page 1.
- K101091: Z.One Ultra Ultrasound System, Zonare Medical Systems, Inc. (2010) Summary page 1.

## Most influential descendants
- K161960: bk2300 (2016), 5 descendants of its own
- K180737: Ultrasound Scanner System bk2300 (2018), 2 descendants of its own
- K222441: Ultrasound System 2300 (2022), 1 descendant of its own
- K173569: Ultrasound System 1300 (2018), 1 descendant of its own
- K231764: Ultrasound System 1300 (2023), 0 descendants of its own

## Indications for use
The PET-512MC is a transesophageal transducer (TEE) designed for use with Toshiba Diagnostic Ultrasound System for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

Source page: https://510kreport.com/device/K103629
Methodology: https://510kreport.com/methodology