# K990806: C1 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Mar 26, 1999 after 15 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
Longest line of descent: 1 generation back to K981505 (1998). 1 ancestor in all.
232 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)
- K981505: Cozumel Diagnostic Ultrasound System, Sonosite,Inc. (1998). Our OCR of the scanned summary read “K981505.” beside “510(k)”; FDA’s K981505 is the only number that fits it and carries the summary’s name for the device. Summary page 8.
- (no number) Medison SAB88 Plus diagnostic ultrasound system: named in the summary without a submission number
- (no number) Cozumel ultrasound system: named in the summary without a submission number

## Most influential descendants
- 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
- K102153: Mobius Ultrasound Imaging System (2011), 103 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/K990806
Methodology: https://510kreport.com/methodology