# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: Sep 27, 2022 after 26 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (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.
1 later device descends from it; 1 cites it directly.
6 of 198 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 6.

## Most influential descendants
- K242800: The 5000 Compact Series Ultrasound Systems (2024), 0 descendants of its own

## Recalls of this device
- Mar 23, 2024 · Class II · Z-1757-2024: Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer remove
- Jun 30, 2023 · Class II · Z-2517-2023: Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage,

## Indications for use
The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes. 5000 Compact series is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Pediatric, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology. The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians’ office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings 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. However, nothing stated in the user information reduces the user’s responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

Source page: https://510kreport.com/device/K222648
Methodology: https://510kreport.com/methodology