# K130499: IU22 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jun 18, 2013 after 112 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: 14 generations back to K935595 (1995). 73 ancestors in all.
212 later devices descend from it; 1 cites it directly.
2 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 1.
- K112255: Aixplorer, Supersonic Imagine (2012) Summary page 1.

## Most influential descendants
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own
- K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own
- K163120: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System (2017), 58 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2352-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2049-2025: Ultrasound transducer devices were refurbished beyond their useful life.

## 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 (including ElastPQ Liver). Itis 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 Diagnostic Ultrasound System can be used include Clinical, Hospita!, and point-of-care for diagnosis of patients.

Source page: https://510kreport.com/device/K130499
Methodology: https://510kreport.com/methodology