# K072365: Sequoia Plus Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decided: Oct 17, 2007 after 55 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K935595 (1995). 23 ancestors in all.
233 later devices descend from it; 6 cite it directly.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063085: Modification to Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 3.
- K051139: Acuson Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 3.

## Most influential descendants
- K103677: M7/M7T Diagnostic Ultrasound System (2011), 123 descendants of its own
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System (2011), 116 descendants of its own
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own
- K102017: SC2000 Diagnostic Ultrasound System (2010), 104 descendants of its own
- K120699: DC-T6 Diagnostic Ultrasound System (2012), 103 descendants of its own

## Recalls of this device
- Sep 29, 2010 · Not classified · Z-0826-2011: There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
- Sep 29, 2010 · Not classified · Z-0827-2011: There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
- Jul 10, 2009 · Not classified · Z-2149-2011: Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.

## 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: Ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound fluid flow analysis of the human body as follows: Ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K072365
Methodology: https://510kreport.com/methodology