# K202216: EPIQ Series Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Sep 2, 2020 after 27 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K935595 (1995). 196 ancestors in all.
21 later devices descend from it; 2 cite it directly.
6 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200304: EPIQ Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2020) Summary page 5.

## Most influential descendants
- K211597: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (2021), 17 descendants of its own
- K233788: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (2024), 16 descendants of its own
- K240850: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (2024), 14 descendants of its own
- K243794: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (2025), 5 descendants of its own
- K242020: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (2024), 3 descendants of its own

## Recalls of this device
- 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-2404-2025: 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-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-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.

## Indications for use
The intended use of Philips 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), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. The clinical environments where Philips EPIQ 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/K202216
Methodology: https://510kreport.com/methodology