# K082098: Sonosite Maxx Series Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Aug 25, 2008 after 31 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945773 (1995). 21 ancestors in all.
247 later devices descend from it; 7 cite it directly.
0 of 269 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.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.
- K034003: Hdi 5000 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001) Summary page 1.
- K061129: GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K113156: Sonosite Edge Ultrasound System (2011), 216 descendants of its own
- 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

## Recalls of this device
- Jul 18, 2011 · Not classified · Z-0057-2012: This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S
- May 27, 2010 · Not classified · Z-2116-2010: PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.

## Indications for use
The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skel. (Conventional) Musculo-skel. (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral vessel SiteLinkTM Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC. The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx SeriesTM medical diagnostic ultrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Source page: https://510kreport.com/device/K082098
Methodology: https://510kreport.com/methodology