FDA product code IXG: Phantom, Anthropomorphic, Radiographic
IXG is the FDA product code for phantom, anthropomorphic, radiographic. It is a Class I device, regulated under 21 CFR 892.1950 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under IXG, from 4 different applicants. The average 510(k) review took 67 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Phantom, Anthropomorphic, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1950 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IXG clearance
Top IXG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bennett X-Ray Corp. | 1 | 1991-09-19 |
| Computerized Imaging Reference Systems, Inc. | 1 | 1985-09-26 |
| Imatron, Inc. | 1 | 1984-02-21 |
| Cirs, Inc. | 1 | 1984-02-21 |
Most recent IXG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913243 | Bennett X-Ray Corp. | BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE | 1991-09-19 | 59 |
| K852528 | Computerized Imaging Reference Systems, Inc. | BONE DENSITY CT PHANTOM | 1985-09-26 | 104 |
| K840131 | Imatron, Inc. | COMPUTED TOMOGRAPHY CALIBRATION PHANT | 1984-02-21 | 42 |
| K834465 | Cirs, Inc. | SERIES OF DIAGNOSTIC PHANTOMS | 1984-02-21 | 63 |
Recalls for IXG devices
openFDA lists no recalls for product code IXG.
Frequently asked questions
What is FDA product code IXG?
IXG is the FDA product code for phantom, anthropomorphic, radiographic. It is a Class I device, regulated under 21 CFR 892.1950 and reviewed by the Radiology panel.
What device class is IXG?
Class I, regulation 21 CFR 892.1950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXG?
Across 4 cleared submissions the average was 67 days from receipt to decision (median 61).
Which companies have the most IXG clearances?
Bennett X-Ray Corp. (1); Computerized Imaging Reference Systems, Inc. (1); Imatron, Inc. (1); Cirs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXG
- Run a recall and safety report across every IXG manufacturer
- Watch product code IXG 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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