# K260667: Alturion Series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: Jun 29, 2026 after 119 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). 284 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243794: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System, Philips Ultrasound, LLC (2025) Summary page 5.

## Most influential descendants
- K262311: Alturion Series Diagnostic Ultrasound System (2026), 0 descendants of its own

## Indications for use
The Alturion Series Diagnostic Ultrasound System is indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body in 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), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of Operation include B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. The clinical environments where the Alturion Series Diagnostic Ultrasound System can be used include clinics, hospitals, and clinical point-of-care 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 your responsibility for sound clinical judgement and best clinical procedure.

Source page: https://510kreport.com/device/K260667
Methodology: https://510kreport.com/methodology