CareView 1500P X-ray Flat Panel Detectors
by Careray Digital Medical System Co., Ltd.
510(k) K162178
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162178 | Date1 Sep 2016 | 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- Withdrawn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, 22 Sep 2026
The CareView 1500P X-ray Flat Panel Detectors are portable, wireless digital X-ray flat panel detectors with a 434mm x 355mm imaging area. The device intercepts X-ray photons, and the scintillator emits visible light that is converted to electrical signals by an amorphous silicon (a-Si) array, which are then digitized for display on a monitor.
The device is intended for radiographic diagnosis of human anatomy and is designed to replace radiographic film/screen systems in all applications. It is supplied as a reusable device and is not specified as MRI safe. The device is authorized under FDA 510K with K number K162178 and product code MQB.
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Questions
AI-generated answers, 22 Sep 2026
What is the purpose of the CareView 1500P X-ray Flat Panel Detectors?
The CareView 1500P X-ray Flat Panel Detectors are intended for radiographic diagnosis of human anatomy and are designed to replace radiographic film/screen systems in all applications. They intercept X-ray photons and convert them to digital images for display on a monitor.
How is the CareView 1500P X-ray Flat Panel Detector supplied and is it reusable?
The device is supplied as a reusable device. It is not specified as MRI safe and is intended for multiple uses in radiographic diagnostic procedures after appropriate cleaning and disinfection between patients.
What are the specifications of the CareView 1500P X-ray Flat Panel Detector?
The CareView 1500P is a portable, wireless digital X-ray flat panel detector with a 434mm x 355mm imaging area. It uses a scintillator that emits visible light when exposed to X-ray photons, which is then converted to electrical signals by an amorphous silicon (a-Si) array and digitized for display.
What is the regulatory status of the CareView 1500P X-ray Flat Panel Detector?
The device is authorized under FDA 510K with K number K162178 and product code MQB. It has been determined to be substantially equivalent to predicate devices for radiographic diagnosis of human anatomy.