# K042540: Philips IU22 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Oct 4, 2004 after 14 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934139 (1995). 7 ancestors in all.
882 later devices descend from it; 12 cite it directly.
6 of 890 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040227: Qlab Quantification Software, Philips Ultrasound (2004) Summary page 1.
- K022824: Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X, Tomtec Imaging Systems GmbH (2002) Summary page 1.
- K022303: Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer, Philips Ultrasound, Inc. (2002) Summary page 1.

## Most influential descendants
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K102041: Aixplorer (2010), 527 descendants of its own
- K112255: Aixplorer (2012), 525 descendants of its own
- K121329: Aixplorer (2012), 405 descendants of its own
- K132274: Aixplorer (2013), 312 descendants of its own

## Recalls of this device
- Sep 5, 2025 · Class III · Z-1627-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2407-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2058-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- Jun 30, 2023 · Class II · Z-2517-2023: Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage,

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

Source page: https://510kreport.com/device/K042540
Methodology: https://510kreport.com/methodology