FUJI FCR IMAGE PROCESSING UNIT IP-U515
Device Facts
| Record ID | K942561 |
|---|---|
| Device Name | FUJI FCR IMAGE PROCESSING UNIT IP-U515 |
| Applicant | Fujifilm Medical System U.S.A., Inc. |
| Product Code | IXK · Radiology |
| Decision Date | Dec 23, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
