# K022303: Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jul 30, 2002 after 14 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002470 (2000). 2 ancestors in all.
1,155 later devices descend from it; 2 cite it directly.
6 of 1,158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002470: M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A Transducer, Agilent Technologies, Inc. (2000) Summary page 1.
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.

## Most influential descendants
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 descendants of its own
- K042540: Philips IU22 Ultrasound System (2004), 882 descendants of its own
- K063085: Modification to Acuson Sequoia Ultrasound System (2006), 838 descendants of its own
- K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer (2005), 806 descendants of its own

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

Source page: https://510kreport.com/device/K022303
Methodology: https://510kreport.com/methodology