Cm & Cm Ds-7
by Konica Medical Corp. 510(k)
Active
510(k) K963914
Overview
The CM & CM DS-7 Mammography Cassette is a radiographic film cassette designed for use in diagnostic imaging, specifically within mammography procedures. It serves as a light-tight container to protect X-ray film during exposure and processing, ensuring optimal image quality by preventing light contamination.
This device is supplied as a reusable radiographic accessory and is intended for use in radiology settings. It has received FDA 510(k) clearance under the classification of Class II (product code: IXA), with a decision date of October 8, 1997. The cassette adheres to regulatory standards for radiographic film cassettes, including those outlined in 21 CFR 892.1850.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963914 | Date8 Oct 1997 | 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- Withdrawn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
- IXA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1850
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Konica Medical Corp.
Questions
What is the primary purpose of the CM & CM DS-7 Mammography Cassette in a clinical setting?
The CM & CM DS-7 Mammography Cassette is designed specifically for mammography procedures to act as a light-tight container for X-ray film. Its purpose is to protect the film during exposure and processing, ensuring high-quality diagnostic images by preventing light contamination that could degrade image clarity.
Is the CM & CM DS-7 Mammography Cassette intended for single-use or reusable applications?
The CM & CM DS-7 is explicitly described as a reusable radiographic accessory, meaning it is built for repeated use in radiology settings after proper cleaning and maintenance. This aligns with its classification as a reusable component in diagnostic imaging workflows.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The CM & CM DS-7 received FDA clearance through a 510(k) submission, classified under product code IXA and determined to be substantially equivalent to a predicate device. This means the device was evaluated by the FDA’s Radiology (RA) Advisory Committee and deemed compliant with 21 CFR 892.1850 standards for radiographic film cassettes, ensuring it meets established safety and performance criteria for use in mammography.
How should the CM & CM DS-7 Mammography Cassette be stored to maintain its integrity?
While the provided data does not specify storage conditions, as a reusable radiographic cassette, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Proper handling and maintenance (e.g., cleaning and inspection) are critical to preserving its light-tight seal and functionality over repeated uses.