21 CFR 892.1920 — Holder, Head, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1920
Identification
A radiographic head holder is a device intended to position the patient's head during a 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWY | Holder, Head, Radiographic | 1 | 10 |
