Test-Pattern, Radiographic
FDA product code IXF · Class I (low risk) · 21 CFR 892.1940 · Radiology
5510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K865100 | Tissue-Equivalent Breast SimulatorIXF · Traditional | Computerized Imaging Reference Systems, Inc. | 01/12/1987SE |
| K851812 | Digital Subtraction Antiography Phantom 76-700/711IXF · Traditional | Victoreen, Inc. | 06/05/1985SE |
| K834482 | Tissue Mimicking Ultrasound PhantomsIXF · Traditional | Radiation Measurements, Inc. | 01/25/1984SE |
| K834481 | Doppler Phantom Flow Control SysIXF · Traditional | Radiation Measurements, Inc. | 01/25/1984SE |
| K810254 | 1.5` Focal Spot Resolution PatternIXF · Traditional | Machlett Laboratories, Inc. | 02/19/1981SE |