Compact Daylight System II
by E.I. Dupont DE Nemours & Co., Inc.
510(k) K924552
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924552 | Date7 Dec 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Du Pont Compact Daylight System II (Cds II)
- 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 Compact Daylight System II is an automatic radiographic film processor, classified under the device type 'Processor, Radiographic-Film, Automatic.' It is designed to automatically develop, fix, wash, and dry exposed medical radiographic film in a continuous process. This system is intended for use in radiology settings to produce processed film images for diagnostic evaluation. Its function aligns with standard radiographic film processing workflows, ensuring consistent and efficient film development.
The device is supplied as a reusable medical instrument and is intended for use in radiology departments. It operates under standard environmental conditions and does not require special sterility measures beyond routine cleaning and maintenance. The Compact Daylight System II is regulated under FDA 510(k) clearance (K924552) and falls under the classification of Class II devices with special controls. It adheres to regulatory standards outlined in 21 CFR 892.1900, ensuring compliance with safety and performance requirements for automatic radiographic film processors.
Other devices from E.I. Dupont DE Nemours & Co., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the DuPont Compact Daylight System II (CDS II) used for?
The CDS II is an automatic radiographic film processor designed to develop, fix, wash, and dry exposed medical radiographic film in a continuous process. It streamlines workflows in radiology departments by ensuring rapid, consistent film processing for diagnostic evaluation, aligning with standard radiographic workflows.
Is the CDS II a single-use or reusable device?
The CDS II is a reusable medical instrument. It is intended for repeated use in radiology settings, provided it undergoes routine cleaning and maintenance as specified by the manufacturer to maintain performance and safety standards.
What regulatory clearance does the CDS II hold?
The CDS II holds FDA 510(k) clearance under the classification of Class II devices with special controls. It is regulated under 21 CFR 892.1900, ensuring compliance with safety and performance requirements for automatic radiographic film processors. The clearance number is K924552.
Does the CDS II require special sterility measures beyond routine cleaning?
No, the CDS II does not require special sterility measures beyond standard cleaning and maintenance procedures. Since it is a reusable device, adherence to manufacturer guidelines for disinfection and upkeep is essential to prevent contamination and ensure reliable operation.
What type of radiology settings is the CDS II intended for?
The CDS II is specifically designed for use in radiology departments where exposed radiographic film needs to be processed efficiently. Its automated functions make it suitable for clinical environments where consistent, high-quality film development is critical for diagnostic purposes.