# K211248: ArtUs

- Pathway: 510(k) (Traditional)
- Applicant: Telemed
- Decided: Feb 11, 2022 after 291 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: 16 generations back to K924432 (1993). 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)
- K163121: SmartUs EXT-1M/3M, Telemed (2017) Summary page 4.
- K112646: Sonoace R7 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 4.

## Indications for use
ArtUs is a general purpose diagnostic ultrasound imaging system intended for use by qualified and appropriately trained healthcare professionals to conduct ultrasound scan process or fluid flow analysis of the human body. It is intended to be used for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles), Musculo-Skeletal Conventional and Superficial, Cardiac (adult and pediatric), Adult Cephalic, and Peripheral Vascular. Modes of operation include B, M, Pulse Wave Doppler (PWD), Color Doppler (CFM), Power Doppler (PDI), Directional Power Doppler (DPDI), Combined modes (B+B, B+M, 4B, B+PWD (Duplex), B+CFM/PDI/DPDI+PWD (Triplex)), Tissue Harmonic Imaging (THI) and Inverted Tissue Harmonic Imaging (ITHI). The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Source page: https://510kreport.com/device/K211248
Methodology: https://510kreport.com/methodology