# K981505: Cozumel Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: May 8, 1998 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
No predicates in its family tree.
233 later devices descend from it; 2 cite it directly.
3 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Atl Hdi® 5000: named in the summary without a submission number
- (no number) Medison SA600 diagnostic ultrasound systems: named in the summary without a submission number
- (no number) ATL Ultramark® 4 system: named in the summary without a submission number

## Most influential descendants
- K990806: C1 Ultrasound System (1999), 232 descendants of its own
- K994096: Sonoheart Hand-Carried Echocardiography System (1999), 196 descendants of its own
- K063761: Acuson P10 Diagnostic Ultrasound System (2007), 135 descendants of its own
- K092756: GE Vscan Compact Diagnostic Ultrasound System (2009), 130 descendants of its own
- K090505: Speq Ultrasound System (2009), 107 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K981505
Methodology: https://510kreport.com/methodology