# K254027: Digital Color Doppler Ultrasound System  (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: Aug 24, 2026 after 251 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: 26 generations back to K935595 (1995). 214 ancestors in all.
No later device cites it as a predicate yet.
6 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222596: S90 Exp Series Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2023) Summary page 7.

## Indications for use
The Marvo Senior Series Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging system intended for use by qualified and appropriately trained healthcare professionals for ultrasound imaging, measurement, and analysis of the human body, which is intended to be used in a hospital or medical clinic. The system is intended for use in the following clinical applications: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave Elastography, Contrast imaging and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

Source page: https://510kreport.com/device/K254027
Methodology: https://510kreport.com/methodology