# K081843: Ultrasound Data Analysis System, Model Das-RS1

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Jul 15, 2008 after 15 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: 1 generation back to K021966 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.

## Indications for use
The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

Source page: https://510kreport.com/device/K081843
Methodology: https://510kreport.com/methodology