Jpi X-Ray Film Cassette
by Jpi, Inc. 510(k)
Active
510(k) K930244
Overview
The Jpi X-Ray Film Cassette is a radiographic film cassette intended for use during diagnostic x-ray procedures. It functions to hold radiographic film in close contact with an x-ray intensifying screen while providing a light-proof enclosure for direct exposure of the film.
This device is classified as a Class II medical device under regulation number 892.1850. It has received FDA 510(k) clearance under K930244.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930244 | Date7 Apr 1993 | 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- Withdrawn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