# K934915: Acuson Model 2001

- Pathway: 510(k) (Traditional)
- Applicant: Acuson Corp.
- Decided: Oct 21, 1994 after 371 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.
1,096 later devices descend from it; 2 cite it directly.
2 of 1,097 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
- K991805: Aspen Ultrasound with Freestyle Imaging Option (1999), 1,093 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
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own

Source page: https://510kreport.com/device/K934915
Methodology: https://510kreport.com/methodology