# K220983: ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Imsonic Medical China, Inc.
- Decided: Nov 11, 2022 after 221 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: 12 generations back to K945773 (1995). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System, FUJIFILM Sonosite, Inc. (2015) Summary page 4.

## Indications for use
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include: Fetal/obstetric Gynecological /Pelvic Abdominal Renal Cardiac Pediatric Small organ (thyroid, breast, testes, etc.) Musculoskeletal (conventional & superficial) Peripheral vascular Ophthalmic Modes of operation include B, M, PWD(PW), Color Doppler (C ), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).

Source page: https://510kreport.com/device/K220983
Methodology: https://510kreport.com/methodology