FDA product code IXD: Source, Calibration, Sealed, Nuclear
IXD is the FDA product code for source, calibration, sealed, nuclear. It is a Class I device, regulated under 21 CFR 892.1400 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under IXD, from 2 different applicants. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Source, Calibration, Sealed, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1400 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXD clearance
Top IXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syncor Intl. Corp. | 1 | 1985-03-26 |
| Amersham Corp. | 1 | 1981-09-09 |
Most recent IXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850208 | Syncor Intl. Corp. | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | 1985-03-26 | 67 |
| K812235 | Amersham Corp. | GOLD(AU 195) SPOT MARKER SOURCES | 1981-09-09 | 29 |
Recalls for IXD devices
openFDA lists no recalls for product code IXD.
Frequently asked questions
What is FDA product code IXD?
IXD is the FDA product code for source, calibration, sealed, nuclear. It is a Class I device, regulated under 21 CFR 892.1400 and reviewed by the Radiology panel.
What device class is IXD?
Class I, regulation 21 CFR 892.1400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXD?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most IXD clearances?
Syncor Intl. Corp. (1); Amersham Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXD
- Run a recall and safety report across every IXD manufacturer
- Watch product code IXD 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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