# K061605: Nemio XG, Saa-580A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 22, 2006 after 13 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010631 (2001). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010631: NEMIO, Toshiba America Medical Systems, In.C (2001) Summary page 1.

## Most influential descendants
- K151060: Ultrasound System SONIMAGE HS1 (2015), 4 descendants of its own
- K152577: Ultrasound System Sonimage HS 1 (2015), 3 descendants of its own
- K162065: Ultrasound System SONIMAGE HS1 (2016), 2 descendants of its own
- K180084: Ultrasound System SONIMAGE MX1 (2018), 1 descendant of its own
- K220993: Ultrasound System SONIMAGE MX1 (2022), 0 descendants of its own

## Recalls of this device
- Aug 29, 2007 · Not classified · Z-0254-2008: Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display 
- Dec 19, 2006 · Not classified · Z-0771-2007: Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exce

## Indications for use
The Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K061605
Methodology: https://510kreport.com/methodology