# K043078: Nemio Diagnostic Ultrasound System, Model Ssa-550A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 17, 2004 after 9 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 5 generations back to K935595 (1995). 20 ancestors in all.
196 later devices descend from it; 1 cites it directly.
0 of 217 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.
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K051500: Famio Diagnostic Ultrasound Systems, Model Ssa-530A (2005), 195 descendants of its own
- K053346: Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900 (2005), 194 descendants of its own
- K061189: DP-9900 Digital Ultrasonic Diagnostic Imaging System (2006), 193 descendants of its own
- K063500: DC-6 Diagnostic Ultrasound System (2006), 189 descendants of its own
- K072164: DC-6 Diagnostic Ultrasound System (2007), 188 descendants of its own

## Recalls of this device
- Aug 29, 2007 · Not classified · Z-0253-2008: 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 

## Indications for use
The NEMIO systems are 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), and laparoscopic.

Source page: https://510kreport.com/device/K043078
Methodology: https://510kreport.com/methodology