# K001400: Elegra Millennium Enhanced Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 1, 2000 after 90 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
982 later devices descend from it; 2 cite it directly.
2 of 983 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
- K050034: Sonoline Antares Diagnostic Ultrasound System (2005), 921 descendants of its own
- K023720: Sonoline Antares Ultrasound System (2002), 896 descendants of its own
- 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

## Recalls of this device
- Sep 5, 2003 · Not classified · Z-0041-04: Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.

Source page: https://510kreport.com/device/K001400
Methodology: https://510kreport.com/methodology