# K113663: Sonixtablet Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Jan 25, 2012 after 43 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: 14 generations back to K935595 (1995). 108 ancestors in all.
75 later devices descend from it; 1 cites it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102997: Sonixtablet Ultrasound Scanner, Ultrasonix Medical Corporation (2010) Summary page 2.

## Most influential descendants
- 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
- K142876: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (2014), 58 descendants of its own
- K152369: ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System (2015), 54 descendants of its own

## Indications for use
The SonixTABLET Ultrasound Scanner is intended for the following applications: Abdominal, Cardiac, lntraoperative 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 dataobtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K113663
Methodology: https://510kreport.com/methodology