CareView 1800L
by Careray Digital Medical System Co., Ltd.
510(k) K153492
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153492 | Date24 Dec 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The CareView 1800L is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed as a tethered cassette-style detector for digital radiography. It features a scintillator matrix with 2816 x 2816 pixels and a pixel pitch of 154 µm, enabling high-resolution imaging. This device converts X-ray exposure into digital signals for real-time radiographic visualization, supporting both medical and veterinary applications. Its compact design integrates seamlessly into mobile healthcare workflows while maintaining performance standards for diagnostic imaging.
The CareView 1800L is supplied as a reusable, non-sterile device intended for use in radiology settings. It operates with a low-power design, capable of storing up to 1400 images per charge, and features full-field AED compatibility for broad system integration. The detector measures 46.0 x 46.0 x 1.5 cm and is classified as a Class II medical device under FDA regulations (K153492, 510(k) clearance via Special Review, Radiology Advisory Committee). Storage and handling follow standard radiography protocols, with no MRI safety restrictions specified.
Other devices from Careray Digital Medical System Co., Ltd.
See all devices from Careray Digital Medical System Co., Ltd. →
Questions
AI-generated answers, 20 Sep 2026
What types of medical and veterinary settings can the CareView 1800L be used in, and how does its design support mobile workflows?
The CareView 1800L is designed for both medical and veterinary radiography applications, enabling high-resolution imaging for diagnostic purposes. Its compact, tethered cassette-style detector—measuring 46.0 x 46.0 x 1.5 cm—is optimized for seamless integration into mobile healthcare environments, such as portable radiography units or veterinary clinics, without compromising image quality or performance.
Is the CareView 1800L single-use or reusable, and what does that mean for maintenance and cleaning?
The CareView 1800L is a reusable device, meaning it is not intended for single-use disposal. This design allows for cost-effective use over time, but it requires adherence to standard radiography protocols for cleaning, maintenance, and storage to ensure longevity and prevent cross-contamination between patients or procedures.
How many images can the CareView 1800L store before needing to be recharged, and what does its low-power design imply for operational efficiency?
The CareView 1800L can store up to 1,400 images per charge, which enhances operational efficiency by reducing the need for frequent recharging during busy workflows. Its low-power design also contributes to extended battery life, making it suitable for prolonged use in clinical settings where downtime for recharging could disrupt diagnostic workflows.
What are the dimensions of the CareView 1800L, and how does its size compare to traditional cassette-based detectors?
The CareView 1800L measures 46.0 x 46.0 x 1.5 cm, which is comparable in footprint to many traditional cassette-based detectors but with a significantly reduced thickness due to its solid-state design. This compactness allows for easier handling, storage, and integration into existing radiography equipment without requiring additional space.
Does the CareView 1800L require any special handling or storage conditions, and can it be used in environments with MRI equipment?
The CareView 1800L follows standard radiography protocols for storage and handling, which generally include protection from physical damage, extreme temperatures, and moisture. However, there are no MRI safety restrictions specified for this device, meaning it can be used in radiology settings that also house MRI equipment, provided standard electromagnetic interference guidelines are followed.