CR-Pro
by Eradlink, Inc. 510(k)
Active
510(k) K052938
Overview
The CR-Pro is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed to digitize radiographic film transparency images (phosphor plates) into digital format. It employs a 35mW solid-state laser beam guided by fiber optics to scan plates ranging from 10 to 14 inches wide, converting the scanned data into a 16-bit digital grayscale output.
This device operates in radiology settings as a single-use or reusable scanner (depending on plate type) and is non-MRI-safe. Supplied as part of a radiographic workflow, it requires no internal optics cleaning or alignment. Authorized under FDA 510(k) clearance (K052938), it adheres to 21 CFR 892.1680 and is classified as Class II. Multiple FEI numbers (e.g., 3009717300) identify its regulatory variants.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052938 | Date17 Nov 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Eradlink, Inc.
Questions
What types of radiographic plates does the CR-Pro support, and how does it convert them into digital images?
The CR-Pro is designed to digitize radiographic film transparency images, specifically phosphor plates that measure between 10 to 14 inches in width. It uses a 35mW solid-state laser beam guided by fiber optics to scan these plates, converting the scanned data into a 16-bit digital grayscale output for digital imaging.
Is the CR-Pro intended for single-use or reusable applications, and what does this mean for my workflow?
The CR-Pro can be used with either single-use or reusable plates, depending on the type of phosphor plate being scanned. This flexibility allows you to choose between disposable plates for convenience or reusable plates to reduce waste, depending on your facility’s workflow and cost considerations.
What are the key storage and handling requirements for the CR-Pro, particularly regarding its laser and environmental needs?
The CR-Pro does not require internal optics cleaning or alignment, simplifying maintenance. However, since it uses a solid-state laser, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to ensure optimal performance and longevity of the laser components.
How do I determine if the CR-Pro model I’m considering aligns with my facility’s regulatory requirements?
The CR-Pro comes in multiple regulatory variants, each identified by a unique FDA Establishment Identifier (FEI) number (e.g., 3009717300). These variants are all authorized under FDA 510(k) clearance (K052938) and classified as Class II. Verify the FEI number on your device matches the one required by your facility’s procurement or compliance protocols.
Can the CR-Pro be used in an MRI environment, and what safety precautions should I take?
The CR-Pro is explicitly labeled as not MRI-safe, meaning it should never be placed in an MRI environment. Always ensure the device is stored and operated in non-MRI areas to avoid interference with imaging equipment or potential safety hazards.