# K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Philips Health Care - Decided: Oct 4, 2017 after 35 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: 18 generations back to K935595 (1995). 193 ancestors in all. 28 later devices descend from it; 1 cites it directly. 6 of 222 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K163120: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2017) Summary page 4. - K121781: Echonavigator Release 1, Philips Medical Systems Nederland B.V. (2012) Summary page 62. ## Most influential descendants - K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (2018), 27 descendants of its own - K200304: EPIQ Diagnostic Ultrasound System (2020), 24 descendants of its own - K202216: EPIQ Series Diagnostic Ultrasound Systems (2020), 21 descendants of its own - K182857: EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2018), 19 descendants of its own - K201012: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (2020), 18 descendants of its own ## Recalls of this device - Sep 5, 2025 · Class III · Z-1628-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Sep 5, 2025 · Class III · Z-1622-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2411-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2393-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2360-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2405-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2414-2025: 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-2398-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2385-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2350-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2355-2025: 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-2395-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2364-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2413-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2380-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2408-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2410-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2349-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2351-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - May 28, 2025 · Class II · Z-2060-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2052-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2067-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2064-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2053-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2061-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2068-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2063-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2065-2025: Ultrasound transducer devices were refurbished beyond their useful life. - Aug 30, 2019 · Class II · Z-1843-2020: 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 ## Indications for use The intended use of the EPIQ series, Affiniti 30, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Fetal/Obstetric, Abdominal, Intraoperative (Vascular), Intraoperative (Cardiac), Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Neonatal), Cephalic (Adult), Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial) Gynecological, Other: Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal (Cardiac), Cardiac other (Fetal), Peripheral Vessel, Cerebral Vascular. When Philips EPIQ system is integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. Source page: https://510kreport.com/device/K172607 Methodology: https://510kreport.com/methodology