# K140869: DCAS I

- Pathway: 510(k) (Traditional)
- Applicant: Gp&P Co., Ltd.
- Decided: Jul 3, 2014 after 91 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: 5 generations back to K842308 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042525: Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy Workstation, Ge Medical Systems Information Technologies (2004) Summary page 1.

## Indications for use
The DCAS i allows the user to look up, keep, and manage all the medical images used in cardiology with Anglo, ECHO, and IVUS images as the basic ones. It allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can record the images of the patient wanted on a CD or DVD. Here, the exclusive viewer allows the user to check the recorded images of the patient in all sorts of environment. In addition, the user can edit and convert the DICOM Cine images into AVM and static images to use them for editing various images and framing a report. Only the user authorized by using the Internet can use this system based on the Web, and in an environment with a wireless network built, the user can look up data through a mobile device. DCAS i images can be used for reference purposes only and cannot be used for precise readings.

Source page: https://510kreport.com/device/K140869
Methodology: https://510kreport.com/methodology