# K212851: EchoSK and EchoSGyn modules for EchoS Family devices

- Pathway: 510(k) (Traditional)
- Applicant: Echolight S.P.A
- Decided: Mar 16, 2022 after 190 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K935595 (1995). 287 ancestors in all.
No later device cites it as a predicate yet.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202683: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic  Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON  NX3, NX3 Elite Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2020) Summary page 4.
- K202514: EchoS Family, Echolight S.P.A (2021) Summary page 4.

## Indications for use
1) EchoSK and EchoSGyn Modules are additional software/hardware modules for EchoS Family devices and they are additions in terms of indication for use of the legally marketed EchoS Family. 2) EchoSK optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately trained professional in a clinical setting for musculoskeletal applications. The EchoSK module can be used both with a convex or a linear probe. 3) EchoSGyn optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately-trained professional in a clinical setting for Fetal and OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures) applications. The EchoSGyn module can be used both with a convex or with an endocavitary probe.

Source page: https://510kreport.com/device/K212851
Methodology: https://510kreport.com/methodology