Kodak Remote Alarm Unit
510(k) K874926
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874926 | Date4 Jan 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IXW
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1900
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Kodak Remote Alarm Unit is a radiographic-film processor alarm device used in radiology settings. It is designed to provide remote monitoring and alerting for automatic radiographic-film processors.
This device is supplied as a reusable unit and was cleared through the FDA 510(k) process under product code IXW. It is intended for use in healthcare facilities where radiographic-film processing occurs, with no indication of sterility, single-use designation, or MRI safety provided in the data.
Other devices from Eastman Kodak Company
Questions
AI-generated answers, 1 Oct 2026
What is the Kodak Remote Alarm Unit used for?
The Kodak Remote Alarm Unit is designed to provide remote monitoring and alerting for automatic radiographic-film processors in radiology settings, helping staff respond to processor issues without being at the unit.
Is the Kodak Remote Alarm Unit reusable or single-use?
The device is supplied as a reusable unit, meaning it is intended for multiple uses over time in healthcare facilities where radiographic-film processing occurs.
How was the Kodak Remote Alarm Unit cleared for market?
The Kodak Remote Alarm Unit was cleared through the FDA 510(k) process under product code IXW, with a substantially equivalent decision granted on January 4, 1988.