# K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Philips Ultrasound, Inc. - Decided: Apr 6, 2016 after 13 days - Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1550 - Recalls of this device: 33 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 16 generations back to K935595 (1995). 125 ancestors in all. 100 later devices descend from it; 5 cite it directly. 6 of 226 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 4. ## Most influential descendants - 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 - 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 (2017), 28 descendants of its own - K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (2018), 27 descendants of its own - K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System (2016), 27 descendants of its own - K200304: EPIQ Diagnostic Ultrasound System (2020), 24 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-2389-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2373-2025: 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-2367-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2412-2025: 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-2403-2025: 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-2380-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - Jul 3, 2025 · Class III · Z-2397-2025: 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-2347-2025: 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-2048-2025: 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-2066-2025: 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-2055-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2062-2025: 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-1841-2020: 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 Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, 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. Source page: https://510kreport.com/device/K160807 Methodology: https://510kreport.com/methodology