# K093462: Sonix Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Nov 20, 2009 after 14 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 106 ancestors in all.
79 later devices descend from it; 2 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083095: Sonixtouch Ultrasound System, Ultrasonix Medical Corporation (2008) Summary page 2.
- K080935: Sonix MDP Ultrasound Scanner, Ultrasonix Medical Corporation (2008) Summary page 2.
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 2.
- K974432: Ultraguide 1000, Ultraguide, Ltd. (1998) Summary page 2.
- K070244: AEGIS, Sentinelle Medical, Inc. (2007) Summary page 2.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 2.
- K062247: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2006) Summary page 2.
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 2.
- K080223: Zura Tee System, Imacor, LLC (2008) Summary page 2.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K061215: Volcano S51 Family of Imaging Systems, Volcano Corporation (2006) Summary page 2.

## Most influential descendants
- K102997: Sonixtablet Ultrasound Scanner (2010), 77 descendants of its own
- K113663: Sonixtablet Ultrasound Scanner (2012), 75 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 descendants of its own
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own
- K140959: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems (2014), 60 descendants of its own

## Indications for use
The Sonix Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K093462
Methodology: https://510kreport.com/methodology