# K013142: Diasus

- Pathway: 510(k) (Traditional)
- Applicant: Dynamic Imaging, Ltd.
- Decided: Oct 5, 2001 after 15 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: 3 generations back to K944485 (1995). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944485: 4000 AU Ultrasound Imaging System, Biosound, Inc. (1995) Summary page 1.
- K980468: AU5 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.
- K990360: AU6, Biosound Esaote, Inc. (1999) Summary page 1.

## Most influential descendants
- K050551: Voyager Personal Imaging Device (2005), 8 descendants of its own
- K132736: Accuro 3000 Ultrasound Scanner (2014), 5 descendants of its own
- K171594: Accuro (2017), 3 descendants of its own
- K243937: Accuro 3S (2025), 2 descendants of its own
- K060800: Seeker/Spark Ultrasound System (2006), 2 descendants of its own

## Indications for use
The Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.

Source page: https://510kreport.com/device/K013142
Methodology: https://510kreport.com/methodology