# K022877: Observer Ultrasound Reporting and Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Vision Chips, Inc.
- Decided: Feb 5, 2003 after 159 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
Longest line of descent: 2 generations back to K955092 (1996). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963610: Aki Compacs Data Compresion Module for Diagnostic Images, A.L.I. Technologies, Inc. (1996) Summary page 2.
- K000443: Remote Fetal Medicine Ultrasound System, R4 Telemedicine, Inc. (2000) Summary page 2.
- K970402: Doctors Review System, Digisonics, Inc. (1997) Summary page 2.

## Most influential descendants
- 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

## Indications for use
OBserver Ultrasound Reporting and Imaging System is intended to automate and enhance the process by which ultrasound examination information is entered and reported and by which ultrasound images are stored and reviewed by physicians in the field of maternal-fetal medicine. The system also provides significant research data for academic institutions.

Source page: https://510kreport.com/device/K022877
Methodology: https://510kreport.com/methodology