# K130173: Sonosite Maxx Series Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Mar 25, 2013 after 60 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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: 8 generations back to K945773 (1995). 49 ancestors in all.
52 later devices descend from it; 4 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082098: Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2008) Summary page 1.
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2010) Summary page 1.
- K113156: Sonosite Edge Ultrasound System, Sonosite,Inc. (2011) Summary page 1.
- K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics, Teratech Corp. (2012) Summary page 1.

## Most influential descendants
- K133454: Sonosite Edge Ultrasound System (2013), 50 descendants of its own
- K142017: X-Porte Ultrasound System (2014), 46 descendants of its own
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System (2015), 45 descendants of its own
- K153626: SonoSite Edge II Ultrasound System (2016), 42 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 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 Maxx Series 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 include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (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/K130173
Methodology: https://510kreport.com/methodology