# K182857: EPIQ Diagnostic Ultrasound System, 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

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Nov 9, 2018 after 30 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 195 ancestors in all.
19 later devices descend from it; 1 cites it directly.
6 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2018) Summary page 17.

## Most influential descendants
- K201012: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (2020), 18 descendants of its own
- 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

## 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.
- 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-2405-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 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-2399-2025: 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-2413-2025: 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-2067-2025: 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.
- May 28, 2025 · Class II · Z-2063-2025: Ultrasound transducer devices were refurbished beyond their useful life.
- Aug 6, 2021 · Class II · Z-2484-2021: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
- Aug 6, 2021 · Class II · Z-2483-2021: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
- Jul 22, 2021 · Class II · Z-2306-2021: Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system,
- Dec 24, 2020 · Class II · Z-0947-2021: Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
- Dec 16, 2020 · Class II · Z-0944-2021: The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow
- Oct 27, 2020 · Class II · Z-0864-2021: The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for differe
- Apr 29, 2019 · Class II · Z-2199-2019: There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of th

## Indications for use
The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 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. 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. 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/K182857
Methodology: https://510kreport.com/methodology