# K060800: Seeker/Spark Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Ardent Sound, Inc.
- Decided: Apr 7, 2006 after 14 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: 4 generations back to K944485 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013142: Diasus, Dynamic Imaging, Ltd. (2001) Summary page 1.
- K980468: AU5 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.
- K000681: AU5, AU6, Biosound Esaote, Inc. (2000) Summary page 1.

## Most influential descendants
- K102253: Echo Blaster (2011), 1 descendant of its own
- K161968: MicrUs (2016), 0 descendants of its own

## Indications for use
B and M-mode imaging for: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ, Pediatric, Cephalic, Transrectal, Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel and Needle Guidance.

Source page: https://510kreport.com/device/K060800
Methodology: https://510kreport.com/methodology