Product code IXF
- Device name
- Test-Pattern, Radiographic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1940
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K865100 | TISSUE-EQUIVALENT BREAST SIMULATOR | Computerized Imaging Reference Systems, Inc. | 1987-01-12 |
| K851812 | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 | Victoreen, Inc. | 1985-06-05 |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Radiation Measurements, Inc. | 1984-01-25 |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Radiation Measurements, Inc. | 1984-01-25 |
| K810254 | 1.5` FOCAL SPOT RESOLUTION PATTERN | Machlett Laboratories, Inc. | 1981-02-19 |
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| 00812266030604 | ECTphan™ | Providus Holdings, Inc. | 2024-03-11 |
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| 00812266030628 | ECTphan™ | Providus Holdings, Inc. | 2024-03-11 |
| 00812266030635 | ECTphan™ | Providus Holdings, Inc. | 2024-03-11 |
| 00812266030642 | ECTphan™ | Providus Holdings, Inc. | 2024-03-11 |
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| 00812266030451 | Catphan® | Providus Holdings, Inc. | 2023-11-07 |
| 00812266030468 | Catphan® | Providus Holdings, Inc. | 2023-11-07 |
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| 00812266030161 | Catphan® | Providus Holdings, Inc. | 2023-10-23 |
| 00812266030178 | Catphan® | Providus Holdings, Inc. | 2023-10-23 |
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