# K193173: CareView 1800Le

- Pathway: 510(k) (Special)
- Applicant: Careray Digital Medical System Co., Ltd.
- Decided: Dec 13, 2019 after 25 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: 10 generations back to K803130 (1981). 27 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153492: CareView 1800L, Careray Digital Medical System Co., Ltd. (2015) Summary page 6.

## Most influential descendants
- K221549: X-ray Flat Panel Detectors (CareView 1800 RF) (2022), 2 descendants of its own
- K223687: X-ray Flat Panel Detectors (EverestView 4343X) (2022), 1 descendant of its own
- K232058: YosemiteView 4343W/YosemiteView 3643W (2023), 0 descendants of its own
- K201932: X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) (2020), 0 descendants of its own

## Indications for use
The CareView 1800Le detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.

Source page: https://510kreport.com/device/K193173
Methodology: https://510kreport.com/methodology