IXG · Phantom, Anthropomorphic, Radiographic
Radiology · 21 CFR 892.1950 · Class 1
Overview
| Product Code | IXG |
|---|---|
| Device Name | Phantom, Anthropomorphic, Radiographic |
| Regulation | 21 CFR 892.1950 |
| Device Class | Class 1 |
| Review Panel | Radiology |
| GMP Exempt | Yes |
Identification
A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.
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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K913243 | BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE | Bennett X-Ray Corp. | Sep 19, 1991 | SESE |
| K852528 | BONE DENSITY CT PHANTOM | Computerized Imaging Reference Systems, Inc. | Sep 26, 1985 | SESE |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | Imatron, Inc. | Feb 21, 1984 | SESE |
| K834465 | SERIES OF DIAGNOSTIC PHANTOMS | Cirs, Inc. | Feb 21, 1984 | SESE |
Top Applicants
- Imatron, Inc. — 1 clearance
- Computerized Imaging Reference Systems, Inc. — 1 clearance
- Cirs, Inc. — 1 clearance
- Bennett X-Ray Corp. — 1 clearance
