21 CFR 892.1770 — Tube Mount, X-Ray, Diagnostic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1770
Identification
A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.
Classification Rationale
Class I (general controls). The device 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 |
|---|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 40 |