21 CFR 892.1680 — System, X-Ray, Stationary
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1680
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | 2 | 355 | 3rd Party |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 421 | 3rd Party |
| MWP | Cabinet, X-Ray System | 2 | 27 | 3rd Party |
| OIO | Radiographic Contrast Tray | 2 | 0 | |
| OIP | Radiology-Diagnostic Kit | 2 | 0 |
Special Controls
KPR — System, X-Ray, Stationary
*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.
eCFR
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
*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.
eCFR
MWP — Cabinet, X-Ray System
*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.
eCFR
OIO — Radiographic Contrast Tray
*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.
eCFR
OIP — Radiology-Diagnostic Kit
*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.
eCFR
