# K182628: Imagio Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Seno Medical Instruments, Inc.
- Decided: Mar 5, 2019 after 162 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: 6 generations back to K945773 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080935: Sonix MDP Ultrasound Scanner, Ultrasonix Medical Corporation (2008) Summary page 5.

## Indications for use
The Imagio Ultrasound Imaging System is intended for the following applications: Abdominal, Small Parts, Musculoskeletal conventional, and Musculoskeletal superficial. The system also provides the ability to measure anatomical structures {abdominal, small organ, and musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The ultrasound platform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into the human body. The system then receives echoes back from the human body, processing them to yield an image on a display. The indications for use included in the Imagio Ultrasound Imaging System comprise a subset of indications supported by the predicate device. Only one of the transducers (L14-5/38) supported by the predicate device are supported on the Imagio Ultrasound Imaging System.

Source page: https://510kreport.com/device/K182628
Methodology: https://510kreport.com/methodology