# K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Nov 16, 2005 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945773 (1995). 15 ancestors in all.
676 later devices descend from it; 13 cite it directly.
0 of 692 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 5.
- K034003: Hdi 5000 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2004)
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001)

## Most influential descendants
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K110943: Logiq E9 (2011), 472 descendants of its own
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 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.
- Feb 5, 2007 · Not classified · Z-0661-2007: Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K053069
Methodology: https://510kreport.com/methodology