# K100598: Penrith Elettra Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Penrith Corporation
- Decided: Nov 19, 2010 after 261 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 K934041 (1994). 36 ancestors in all.
64 later devices descend from it; 3 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 2.
- K052331: Acuson Cypress Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A, Philips Medical Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (2015), 33 descendants of its own
- K162417: Acuson Freestyle Ultrasound System (2016), 29 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own
- K180039: ACUSON P600 Diagnostic Ultrasound System (2018), 25 descendants of its own

## Indications for use
The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial). Diagnostic Imaging or fluid flow analysis of the human body as follows: Diagnostic Imaging or fluid flow analysis of the human body as follows: Diagnostic Imaging or fluid flow analysis of the human body as follows: Diagnostic Imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K100598
Methodology: https://510kreport.com/methodology