# K093563: IU22 Ultrasound System and Transducers

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Feb 1, 2010 after 75 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: 11 generations back to K935595 (1995). 65 ancestors in all.
588 later devices descend from it; 12 cite it directly.
2 of 654 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.
- K023877: Q Lab Quantification Software with Strain Rate Quantification Plug-in, Philips Ultrasound, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 descendants of its own

## Recalls of this device
- Sep 5, 2025 · Class III · Z-1620-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2376-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

## Indications for use
The iU22 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging, Harmonics (Tissue and Contrast) and Elastography modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Intra-operative Abdominal Laparoscopic Pediatric Small Organ Adult and Neonatal Cephalic Trans-rectal Trans-vaginal Musculoskeletal Urology Cardiac (Adult, Pediatric, Trans-esophageal) Fetal Echo Peripheral Vessel The clinical environments where the iU22 3.7 system can be used include point-of-care areas in offices, clinical and hospital settings for diagnosis of patients. 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/K093563
Methodology: https://510kreport.com/methodology