FDA product code IXF: Test-Pattern, Radiographic
IXF is the FDA product code for test-pattern, radiographic. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel. FDA has cleared 5 510(k) submissions under IXF, from 4 different applicants. The average 510(k) review took 31 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Test-Pattern, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1940 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IXF clearance
Top IXF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radiation Measurements, Inc. | 2 | 1984-01-25 |
| Computerized Imaging Reference Systems, Inc. | 1 | 1987-01-12 |
| Victoreen, Inc. | 1 | 1985-06-05 |
| Machlett Laboratories, Inc. | 1 | 1981-02-19 |
Most recent IXF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K865100 | Computerized Imaging Reference Systems, Inc. | TISSUE-EQUIVALENT BREAST SIMULATOR | 1987-01-12 | 13 |
| K851812 | Victoreen, Inc. | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 | 1985-06-05 | 40 |
| K834482 | Radiation Measurements, Inc. | TISSUE MIMICKING ULTRASOUND PHANTOMS | 1984-01-25 | 41 |
| K834481 | Radiation Measurements, Inc. | DOPPLER PHANTOM FLOW CONTROL SYS | 1984-01-25 | 41 |
| K810254 | Machlett Laboratories, Inc. | 1.5` FOCAL SPOT RESOLUTION PATTERN | 1981-02-19 | 20 |
Recalls for IXF devices
openFDA lists no recalls for product code IXF.
Frequently asked questions
What is FDA product code IXF?
IXF is the FDA product code for test-pattern, radiographic. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel.
What device class is IXF?
Class I, regulation 21 CFR 892.1940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXF?
Across 5 cleared submissions the average was 31 days from receipt to decision (median 40).
Which companies have the most IXF clearances?
Radiation Measurements, Inc. (2); Computerized Imaging Reference Systems, Inc. (1); Victoreen, Inc. (1); Machlett Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXF
- Run a recall and safety report across every IXF manufacturer
- Watch product code IXF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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