Kodak Point of Care Cr 120, Kodak Point of Care Cr 140, Kodak Point of Care Cr 260
by Orex Computed Radiography, Ltd.
510(k) K073670
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073670 | Date25 Jan 2008 | 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- Withdrawn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, 6 Oct 2026
The Kodak Point of Care CR 120, CR 140, and CR 260 are solid state X-ray imagers (flat panel/digital imagers) designed for computed radiography. These systems are used for image acquisition and processing in radiology applications, providing digital imaging capabilities at the point of care.
The devices are manufactured by Orex Computed Radiography, Ltd. and have received FDA 510(k) clearance with a decision code of SESE. They are classified as Class II medical devices under product code MQB and regulation number 892.1680. The systems are designed to meet international safety and performance standards and require proper operation by trained personnel.
Other devices from Orex Computed Radiography, Ltd.
Questions
AI-generated answers, 6 Oct 2026
What are the Kodak Point of Care CR systems used for?
The Kodak Point of Care CR 120, CR 140, and CR 260 are solid state X-ray imagers designed for computed radiography. They are used for image acquisition and processing in radiology applications, providing digital imaging capabilities at the point of care.
What is the regulatory status of these devices?
These devices have received FDA 510(k) clearance with a decision code of SESE, indicating they are substantially equivalent to predicate devices. They are classified as Class II medical devices under product code MQB and regulation number 892.1680.
Are these devices reusable or single-use?
The device data does not specify whether these systems are reusable or single-use. As solid state X-ray imagers designed for computed radiography, they appear to be durable medical equipment intended for multiple imaging procedures, but specific usage instructions would be provided in the product documentation.
What sizes and models are available in this product line?
The Kodak Point of Care CR line includes three models: CR 120, CR 140, and CR 260. These models may differ in specifications such as imaging capabilities, size, or features, though the specific differences between models are not detailed in the provided device data.