FDA product code IXO: Synchronizer, Ecg / Respirator, Radiographic
IXO is the FDA product code for synchronizer, ecg / respirator, radiographic. It is a Class I device, regulated under 21 CFR 892.1970 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under IXO, from 4 different applicants. The average 510(k) review took 80 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Synchronizer, Ecg / Respirator, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1970 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXO clearance
Top IXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radiation Measurements, Inc. | 1 | 1986-05-07 |
| Siemens Corp. | 1 | 1981-07-10 |
| Brattle Instrument Corp. | 1 | 1981-04-10 |
| Medrad, Inc. | 1 | 1980-01-09 |
Most recent IXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854976 | Radiation Measurements, Inc. | RMI RESPIRATORY GATING SYSTEM MODEL 301 | 1986-05-07 | 146 |
| K811587 | Siemens Corp. | SIEMENS ANGIOTRON | 1981-07-10 | 35 |
| K810588 | Brattle Instrument Corp. | SYNCHRONIZER #208 | 1981-04-10 | 37 |
| K791959 | Medrad, Inc. | POST EXTRA SYSTOLIC POSTENTLATOR | 1980-01-09 | 100 |
Recalls for IXO devices
openFDA lists no recalls for product code IXO.
Frequently asked questions
What is FDA product code IXO?
IXO is the FDA product code for synchronizer, ecg / respirator, radiographic. It is a Class I device, regulated under 21 CFR 892.1970 and reviewed by the Radiology panel.
What device class is IXO?
Class I, regulation 21 CFR 892.1970. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXO?
Across 4 cleared submissions the average was 80 days from receipt to decision (median 68).
Which companies have the most IXO clearances?
Radiation Measurements, Inc. (1); Siemens Corp. (1); Brattle Instrument Corp. (1); Medrad, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXO
- Run a recall and safety report across every IXO manufacturer
- Watch product code IXO 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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