# K231190: EPIQ Series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: May 12, 2023 after 16 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K935595 (1995). 198 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212704: Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System, Philips Medical Systems (2021) Summary page 4.

## Most influential descendants
- K233545: EPIQ Series Diagnostic Ultrasound System (2023), 0 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2386-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Oct 9, 2023 · Class II · Z-0283-2024: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
- Oct 9, 2023 · Class II · Z-0284-2024: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
- Jul 14, 2022 · Class II · Z-1007-2026: Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

## Indications for use
The intended use of EPIQ Series 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), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. * The clinical environments where EPIQ Series 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. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. * However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Source page: https://510kreport.com/device/K231190
Methodology: https://510kreport.com/methodology