# K030455: Boris Platform Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Philips Ultrasound, Inc. - Decided: Mar 13, 2003 after 30 days - Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1550 - Recalls of this device: 31 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K961459 (1997). 3 ancestors in all. 535 later devices descend from it; 6 cite it directly. 2 of 539 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1. - K991671: Hdi 5000 Diagnostic Ultrasound System, Advanced Technology Laboratories, Inc. (1999) Summary page 1. - K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging, Atl Ultrasound, Inc. (2000) Summary page 1. ## Most influential descendants - K091970: Aixplorer Ultrasound System (2009), 528 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-1625-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Sep 5, 2025 · Class III · Z-1621-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Sep 5, 2025 · Class III · Z-1619-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - 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-2390-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2371-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2368-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2377-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2367-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2379-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2378-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2381-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2402-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2365-2025: 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. - Jul 3, 2025 · Class III · Z-2382-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2359-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2358-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2357-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2366-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2391-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2353-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2363-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - May 28, 2025 · Class II · Z-2050-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2056-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2051-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2057-2025: Ultrasound transducer devices were refurbished beyond their useful life. - Aug 30, 2019 · Class II · Z-1844-2020: The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure t - Aug 30, 2019 · Class II · Z-1842-2020: The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure t - Mar 27, 2011 · Not classified · Z-2062-2011: Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer f - Nov 2, 2006 · Not classified · Z-0422-2007: Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode) ## Indications for use Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Source page: https://510kreport.com/device/K030455 Methodology: https://510kreport.com/methodology