FDA product code IYI: Collimator, Orthovoltage, Therapeutic X-Ray
IYI is the FDA product code for collimator, orthovoltage, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under IYI, from 2 different applicants. The average 510(k) review took 350 days (median 350).
Classification
| Field | Value |
|---|---|
| Device name | Collimator, Orthovoltage, Therapeutic X-Ray |
| Device class | Class II |
| Regulation | 21 CFR 892.5900 |
| 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 IYI clearance
Top IYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Consolidated Radiation Services, Inc. | 1 | 1992-12-17 |
| Victoreen, Inc. | 1 | 1990-12-05 |
Most recent IYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914821 | Consolidated Radiation Services, Inc. | CRS RADIATION BEAM SCANNER | 1992-12-17 | 419 |
| K900932 | Victoreen, Inc. | 37-702 AND 37-703 PC RAINBOW | 1990-12-05 | 280 |
Recalls for IYI devices
openFDA lists no recalls for product code IYI.
Frequently asked questions
What is FDA product code IYI?
IYI is the FDA product code for collimator, orthovoltage, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel.
What device class is IYI?
Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYI?
Across 2 cleared submissions the average was 350 days from receipt to decision (median 350).
Which companies have the most IYI clearances?
Consolidated Radiation Services, Inc. (1); Victoreen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYI
- Run a recall and safety report across every IYI manufacturer
- Watch product code IYI 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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