# K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 17, 2005 after 22 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935595 (1995). 37 ancestors in all.
806 later devices descend from it; 3 cite it directly.
2 of 844 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051139: Acuson Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K042055: Cypress Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K042770: Modification to Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.

## Most influential descendants
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 descendants of its own
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own

## Recalls of this device
- Sep 30, 2009 · Not classified · Z-0896-2011: Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.

## Indications for use
Ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K052021
Methodology: https://510kreport.com/methodology