# K000443: Remote Fetal Medicine Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: R4 Telemedicine, Inc.
- Decided: Apr 24, 2000 after 74 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022877: Observer Ultrasound Reporting and Imaging System (2003), 2 descendants of its own
- K051639: AS-Obgyn Information System; as-Emr System (2005), 1 descendant of its own
- K260205: AS Software Version Asera (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K000443
Methodology: https://510kreport.com/methodology