# K010631: NEMIO

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Mar 15, 2001 after 13 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
203 later devices descend from it; 6 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043078: Nemio Diagnostic Ultrasound System, Model Ssa-550A (2004), 196 descendants of its own
- 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

Source page: https://510kreport.com/device/K010631
Methodology: https://510kreport.com/methodology