# K242800: The 5000 Compact Series Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: Nov 15, 2024 after 59 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K935595 (1995). 197 ancestors in all.
No later device cites it as a predicate yet.
6 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222648: 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W), Philips Ultrasound, LLC (2022) Summary page 5.

## Indications for use
The intended use of the 5000 Compact series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult),Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology. The clinical environments where the systems can be used include physicians' offices, clinics,hospitals, surgical suites, and clinical point-of-care for diagnosis of patients. The System is 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 judgment and best clinical procedure.

Source page: https://510kreport.com/device/K242800
Methodology: https://510kreport.com/methodology