IXF · Test-Pattern, Radiographic
Radiology · 21 CFR 892.1940 · Class 1
Overview
| Product Code | IXF |
|---|---|
| Device Name | Test-Pattern, Radiographic |
| Regulation | 21 CFR 892.1940 |
| Device Class | Class 1 |
| Review Panel | Radiology |
| GMP Exempt | Yes |
Identification
A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
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 (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K865100 | TISSUE-EQUIVALENT BREAST SIMULATOR | Computerized Imaging Reference Systems, Inc. | Jan 12, 1987 | SESE |
| K851812 | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 | Victoreen, Inc. | Jun 5, 1985 | SESE |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Radiation Measurements, Inc. | Jan 25, 1984 | SESE |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Radiation Measurements, Inc. | Jan 25, 1984 | SESE |
| K810254 | 1.5` FOCAL SPOT RESOLUTION PATTERN | Machlett Laboratories, Inc. | Feb 19, 1981 | SESE |
Top Applicants
- Radiation Measurements, Inc. — 2 clearances
- Victoreen, Inc. — 1 clearance
- Machlett Laboratories, Inc. — 1 clearance
- Computerized Imaging Reference Systems, Inc. — 1 clearance
