# K934139: Tomtec Echo-View

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Tomographic Technologies GmbH
- Decided: Jan 25, 1995 after 518 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,289 later devices descend from it; 2 cite it directly.
8 of 1,290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992580: Fetal Assessment Cap (1999), 1,070 descendants of its own
- K022567: Sequoia Signature II Diagnostic Ultrasound System (2002), 1,069 descendants of its own
- K032114: Sequoia 8.0 Diagnostic Ultrasound System (2003), 1,003 descendants of its own
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- K993398: Echo View, Easy View, Omni View (1999), 987 descendants of its own

Source page: https://510kreport.com/device/K934139
Methodology: https://510kreport.com/methodology