# K051639: AS-Obgyn Information System; as-Emr System

- Pathway: 510(k) (Abbreviated)
- Applicant: As Software, Inc.
- Decided: Aug 2, 2005 after 43 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955092 (1996). 5 ancestors in all.
1 later device descends 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)
- K970402: Doctors Review System, Digisonics, Inc. (1997) Summary page 1.
- K000443: Remote Fetal Medicine Ultrasound System, R4 Telemedicine, Inc. (2000) Summary page 1.
- K022877: Observer Ultrasound Reporting and Imaging System, Vision Chips, Inc. (2003) Summary page 1.

## Most influential descendants
- K260205: AS Software Version Asera (2026), 0 descendants of its own

## Recalls of this device
- Sep 20, 2018 · Class II · Z-0118-2019: Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production enviro

## Indications for use
The AS-OBGYN Information System is intended to automate the management of patient information. The system allows image acquisition, review, document, storage, archive and reporting. The AS-OBGYN Information System is intended for use by obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.

Source page: https://510kreport.com/device/K051639
Methodology: https://510kreport.com/methodology