FDR IMAGE STITCHING OPTION
Device Facts
| Record ID | K101686 |
|---|---|
| Device Name | FDR IMAGE STITCHING OPTION |
| Applicant | Fujifilm Medical System U.S.A., Inc. |
| Product Code | KPR · Radiology |
| Decision Date | Oct 29, 2010 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
