FDA product code IXK: System, Imaging, X-Ray, Electrostatic
IXK is the FDA product code for system, imaging, x-ray, electrostatic. It is a Class II device, regulated under 21 CFR 892.1630 and reviewed by the Radiology panel. FDA has cleared 14 510(k) submissions under IXK, from 10 different applicants. The average 510(k) review took 135 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, X-Ray, Electrostatic |
| Device class | Class II |
| Regulation | 21 CFR 892.1630 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IXK clearance
Top IXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujifilm Medical System U.S.A., Inc. | 4 | 1994-12-23 |
| Agfa Corp. | 2 | 2004-10-21 |
| Electron Jsco. | 1 | 2011-04-29 |
| Portavision Medical | 1 | 2007-12-11 |
| Orex Computed Radiography, Ltd. | 1 | 2003-10-09 |
5 more applicants have IXK clearances. See the full list in Caduvo.
Most recent IXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093640 | Electron Jsco. | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | 2011-04-29 | 521 |
| K072766 | Portavision Medical | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | 2007-12-11 | 74 |
| K042779 | Agfa Corp. | RADIOTHERAPY SOLUTION BASED ON CR | 2004-10-21 | 15 |
| K032654 | Orex Computed Radiography, Ltd. | PORT CASSETTE | 2003-10-09 | 42 |
| K003689 | Canon USA, Inc. | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | 2002-01-02 | 398 |
Recalls for IXK devices
openFDA lists no recalls for product code IXK.
Frequently asked questions
What is FDA product code IXK?
IXK is the FDA product code for system, imaging, x-ray, electrostatic. It is a Class II device, regulated under 21 CFR 892.1630 and reviewed by the Radiology panel.
What device class is IXK?
Class II, regulation 21 CFR 892.1630. Typical premarket route: 510(k).
How long does a 510(k) take for product code IXK?
Across 14 cleared submissions the average was 135 days from receipt to decision (median 88).
Which companies have the most IXK clearances?
Fujifilm Medical System U.S.A., Inc. (4); Agfa Corp. (2); Electron Jsco. (1); Portavision Medical (1); Orex Computed Radiography, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXK
- Run a recall and safety report across every IXK manufacturer
- Watch product code IXK 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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