FDA product code IXI: Block, Beam-Shaping, Radiation Therapy
IXI is the FDA product code for block, beam-shaping, radiation therapy. It is a Class II device, regulated under 21 CFR 892.5710 and reviewed by the Radiology panel. FDA has cleared 51 510(k) submissions under IXI, 3 in the last five years, from 36 different applicants. The average 510(k) review took 108 days (median 90); 199 days on average over the last three years. FDA has posted 6 recalls for IXI devices.
Classification
| Field | Value |
|---|---|
| Device name | Block, Beam-Shaping, Radiation Therapy |
| Device class | Class II |
| Regulation | 21 CFR 892.5710 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IXI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 78 |
| 2026 | 1 | 199 |
Compare with all 510(k) review times · Search every IXI clearance
Top IXI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| .Decimal, Inc. | 6 | 2013-10-16 |
| Siemens Medical Solutions USA, Inc. | 5 | 2003-10-02 |
| Cura Medical Technologies, LLC | 2 | 2013-07-30 |
| Mrc Systems GmbH | 2 | 2003-03-17 |
| Med-Tec,Inc. | 2 | 2002-09-27 |
31 more applicants have IXI clearances. See the full list in Caduvo.
Most recent IXI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253025 | Ricoh 3D For Healthcare, LLC | Ricoh 3D for Healthcare Bolus | 2026-04-06 | 199 |
| K222639 | Vha Dean | VHA Radiotherapy Bolus | 2022-11-04 | 64 |
| K214093 | 3D Systems | VSP Bolus | 2022-03-30 | 92 |
| K132236 | .Decimal, Inc. | .DECIMAL PROTON APERTURE | 2013-10-16 | 90 |
| K131150 | Cura Medical Technologies, LLC | CURA COMPENSATOR | 2013-07-30 | 98 |
Recalls for IXI devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-15.
Frequently asked questions
What is FDA product code IXI?
IXI is the FDA product code for block, beam-shaping, radiation therapy. It is a Class II device, regulated under 21 CFR 892.5710 and reviewed by the Radiology panel.
What device class is IXI?
Class II, regulation 21 CFR 892.5710. Typical premarket route: 510(k).
How long does a 510(k) take for product code IXI?
Across 51 cleared submissions the average was 108 days from receipt to decision (median 90).
Which companies have the most IXI clearances?
.Decimal, Inc. (6); Siemens Medical Solutions USA, Inc. (5); Cura Medical Technologies, LLC (2); Mrc Systems GmbH (2); Med-Tec,Inc. (2).
Have IXI devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2013-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code IXI
- Run a recall and safety report across every IXI manufacturer
- Watch product code IXI 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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