# K260680: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

- Pathway: 510(k) (Special)
- Applicant: Philips Ultrasound, LLC
- Decided: May 27, 2026 after 86 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K935595 (1995). 284 ancestors in all.
No later device cites it as a predicate yet.
6 of 285 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243794: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System, Philips Ultrasound, LLC (2025) Summary page 6.

## Recalls of this device
- Aug 7, 2026 · Class II · Z-3249-2026: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnos

## Indications for use
EPIQ Series Diagnostic Ultrasound System: The intended use of EPIQ Series Diagnostic Ultrasound System 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, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. 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. Affiniti Series Diagnostic Ultrasound System: The intended use of Affiniti 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, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. The clinical environments where the Affiniti Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. 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/K260680
Methodology: https://510kreport.com/methodology