# K992580: Fetal Assessment Cap

- Pathway: 510(k) (Traditional)
- Applicant: Acuson Corp.
- Decided: Oct 18, 1999 after 77 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
Longest line of descent: 1 generation back to K934139 (1995). 1 ancestor in all.
1,070 later devices descend from it; 1 cites it directly.
2 of 1,072 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934139: Tomtec Echo-View, Tomtec Tomographic Technologies GmbH (1995) Summary page 1.

## Most influential descendants
- 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
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own

## Indications for use
3D Surface Rendering software can be used with any previously cleared ultrasound system and transducers capable of B-mode imaging and cleared for the above indications for use.

Source page: https://510kreport.com/device/K992580
Methodology: https://510kreport.com/methodology