IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
Device Facts
| Record ID | K072867 |
|---|---|
| Device Name | IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K |
| Applicant | Imix Adr Finland OY |
| Product Code | KPR · Radiology |
| Decision Date | Nov 21, 2007 |
| 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.
