# K991805: Aspen Ultrasound with Freestyle Imaging Option

- Pathway: 510(k) (Traditional)
- Applicant: Acuson Corp.
- Decided: Aug 2, 1999 after 68 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
Longest line of descent: 1 generation back to K934915 (1994). 1 ancestor in all.
1,093 later devices descend from it; 6 cite it directly.
2 of 1,095 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934915: Acuson Model 2001, Acuson Corp. (1994) 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

## Recalls of this device
- Sep 18, 2007 · Not classified · Z-1107-2004: Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condit

## Indications for use
The Aspen Ultrasound System with the FreeStyle option provides B-mode images of anatomy in a field of view that extends well beyond a conventional B-mode region of interest. The FreeStyle option can also provide qualitative Color flow information in this extended field of view. The indications for use for each transducer operating with the FreeStyle feature are unchanged and include fetal, small organ, peripheral vessel, abdominal, gynecologic, transrectal, intraoperative, and musculoskeletal uses.

Source page: https://510kreport.com/device/K991805
Methodology: https://510kreport.com/methodology