# K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Philips Ultrasound, Inc. - Decided: Jul 27, 2018 after 51 days - Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1550 - Recalls of this device: 24 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 19 generations back to K935595 (1995). 194 ancestors in all. 27 later devices descend from it; 2 cite 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) - 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, Philips Health Care (2017) Summary page 5. ## Most influential descendants - 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 - K211597: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (2021), 17 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. - 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-2398-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2399-2025: 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-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. - Jul 3, 2025 · Class III · Z-2369-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - 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. ## Indications for use The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. The clinical environments where the EPIQ and Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients. When 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. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. Source page: https://510kreport.com/device/K181485 Methodology: https://510kreport.com/methodology