# K053306: IVIEW

- Pathway: 510(k) (Traditional)
- Applicant: Ondemandsoft
- Decided: Apr 19, 2006 after 142 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: 6 generations back to K941322 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023473: Sonoreal 3D, Bio Medi Com (2002) Summary page 1.

## Indications for use
The iView[ M is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations. The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device. 31) image reconstructed from this software is referring use only and is not responsible for any diagnosis.

Source page: https://510kreport.com/device/K053306
Methodology: https://510kreport.com/methodology