FDA product code IWX: Barrier, Control Panel, X-Ray, Movable
IWX is the FDA product code for barrier, control panel, x-ray, movable. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under IWX, from 3 different applicants. The average 510(k) review took 25 days (median 21). FDA has posted 1 recall for IWX devices.
Classification
| Field | Value |
|---|---|
| Device name | Barrier, Control Panel, X-Ray, Movable |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWX clearance
Top IWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A2j, Inc. | 1 | 1988-04-27 |
| Victoreen, Inc. | 1 | 1985-04-10 |
| Tecnomed, Inc. | 1 | 1978-07-17 |
Most recent IWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881591 | A2j, Inc. | A2J MZ 45 LASER LIGHT FOR POSITIONING | 1988-04-27 | 14 |
| K850813 | Victoreen, Inc. | MOBILE LEAD PLASTIC X-RAY BARRIERS | 1985-04-10 | 41 |
| K781068 | Tecnomed, Inc. | AUTOMATIC FILM PROCESSORIO M. R80 | 1978-07-17 | 21 |
Recalls for IWX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-11-01.
Frequently asked questions
What is FDA product code IWX?
IWX is the FDA product code for barrier, control panel, x-ray, movable. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWX?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWX?
Across 3 cleared submissions the average was 25 days from receipt to decision (median 21).
Which companies have the most IWX clearances?
A2j, Inc. (1); Victoreen, Inc. (1); Tecnomed, Inc. (1).
Have IWX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code IWX
- Run a recall and safety report across every IWX manufacturer
- Watch product code IWX 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times