# K132304: Epiq Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Philips Ultrasound, Inc. - Decided: Aug 21, 2013 after 28 days - Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1550 - Recalls of this device: 36 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 15 generations back to K935595 (1995). 124 ancestors in all. 211 later devices descend from it; 12 cite it directly. 8 of 336 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K130499: IU22 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 2. - K121498: Percunav, Philips Health Care (2012) Summary page 2. - K093563: IU22 Ultrasound System and Transducers, Philips Ultrasound, Inc. (2010) Summary page 2. - K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 2. - K030455: Boris Platform Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2003) Summary page 1. ## Most influential descendants - K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own - K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own - K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own - 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 - K162549: Lumify Ultrasound System (2016), 43 descendants of its own ## Recalls of this device - 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-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-2352-2025: 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-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-2378-2025: 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-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-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-2359-2025: 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-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-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-2062-2025: Ultrasound transducer devices were refurbished beyond their useful life. - May 28, 2025 · Class II · Z-2049-2025: 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. - Jun 30, 2023 · Class II · Z-2517-2023: Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, - Mar 28, 2016 · Class II · Z-1380-2016: The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from th - Apr 14, 2015 · Class II · Z-1632-2015: When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their - Apr 14, 2015 · Class II · Z-1631-2015: When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their - Apr 10, 2015 · Class II · Z-1579-2015: When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the pat - Apr 10, 2015 · Class II · Z-1578-2015: When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the pat - Nov 5, 2014 · Class II · Z-0816-2015: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection F - Nov 5, 2014 · Class II · Z-0817-2015: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection F - Feb 28, 2014 · Class II · Z-1263-2014: A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sampl - Feb 28, 2014 · Class II · Z-1264-2014: A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sampl - Oct 17, 2013 · Class II · Z-0368-2014: A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age ## Indications for use Fetal/Obstetric Gynecological Intra-operative (Vascular, Cardiac) Abdominal Pediatric Small Organ (Breast, Thyroid, Testicle) Cephalic (Adult, Neonatal) Trans-rectal Trans-vaginal Musculoskeletal (Conventional and Superficial) Urology Cardiac (Adult, Pediatric, Fetal, Trans-esophageal) Fetal Echo Peripheral Vessel Vascular (Cerebral) The clinical environments where the EPIQ Diagnostic Ultrasound System can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients. Source page: https://510kreport.com/device/K132304 Methodology: https://510kreport.com/methodology