# K113156: Sonosite Edge Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Nov 15, 2011 after 20 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945773 (1995). 22 ancestors in all.
216 later devices descend from it; 6 cite it directly.
0 of 239 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071134: Sonosite Maxx Series Diagnostic Ultrasound System, Sonosite,Inc. (2007) Summary page 1.
- K082098: Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2008) Summary page 1.

## Most influential descendants
- K133533: Logiq E (2014), 149 descendants of its own
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 descendants of its own
- K151028: LOGIQ e (2015), 60 descendants of its own
- K133431: VENUE 50 (2013), 60 descendants of its own

## Recalls of this device
- Sep 11, 2013 · Class II · Z-0027-2014: FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.

## Indications for use
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

Source page: https://510kreport.com/device/K113156
Methodology: https://510kreport.com/methodology