# K250030: Flash Ultrasound System 5100 Point of Care

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: Apr 28, 2025 after 112 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 138 ancestors in all.
No later device cites it as a predicate yet.
6 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Philips Health Care (2016) Summary page 5.

## 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-2386-2025: 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-2068-2025: Ultrasound transducer devices were refurbished beyond their useful life.

## Indications for use
The Flash Ultrasound System 5100 Point of Care (5100 POC and 5100 POC Pro) is indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal Adult Cephalic Cardiac Adult Cardiac Pediatric Cerebral Vascular Fetal/OB Lung Musculoskeletal (Conventional) Musculoskeletal (Superficial) Neonatal Cephalic Ophthalmic Other: Carotid Other: GYN Pediatric Peripheral Vessel Small Organ (Breast, Thyroid, Testicle) Trans-Esophageal (Cardiac) Trans-Vaginal Modes of operation include: B Mode (or 2D), Color Doppler, Color Power Angio Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-Mode (including anatomical M-Mode), Harmonics (Tissue), and Combined modes. The clinical environments where the Flash Ultrasound System 5100 POC may be used are: hospitals, surgery centers, clinics, physicians’ offices, diagnostic centers, critical care and emergency room environments, and 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. 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 the user’s responsibility for sound clinical judgment and best clinical procedure.

Source page: https://510kreport.com/device/K250030
Methodology: https://510kreport.com/methodology