# K141488: Careview 1800R

- Pathway: 510(k) (Traditional)
- Applicant: Careray Digital Medical System Co., Ltd.
- Decided: Sep 8, 2015 after 460 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981556 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050987: Digital Radiography Model Cxdi-40EG, Canon, Inc. (2005) Summary page 5.

## Indications for use
CareView 1800R X-ray Flat Panel Detectors is indicated for digital imaging solution designed for providing general radiographic system in all general purpose diagnostic procedures. CareView 1800R X-ray Flat Panel Detectors is a component of a digital imaging system. Properly integrated into a completed X-ray system, the detector enables the digital X-ray imaging intended for medical application. This product is not intended for mammography applications and dental X-ray applications.

Source page: https://510kreport.com/device/K141488
Methodology: https://510kreport.com/methodology