FDA product code IWQ: Curtain, Protective, Radiographic
IWQ is the FDA product code for curtain, protective, radiographic. 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 IWQ, from 3 different applicants. The average 510(k) review took 256 days (median 112).
Classification
| Field | Value |
|---|---|
| Device name | Curtain, Protective, Radiographic |
| 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 IWQ clearance
Top IWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| F. Walter Hanel GmbH | 1 | 1994-12-15 |
| Hydro-Med Products, Inc. | 1 | 1992-10-15 |
| Techton, Inc. | 1 | 1989-04-03 |
Most recent IWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945238 | F. Walter Hanel GmbH | MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 | 1994-12-15 | 49 |
| K923099 | Hydro-Med Products, Inc. | X-RAY DRAPES | 1992-10-15 | 112 |
| K873038 | Techton, Inc. | TECHTON PROTECTIVE PAD | 1989-04-03 | 608 |
Recalls for IWQ devices
openFDA lists no recalls for product code IWQ.
Frequently asked questions
What is FDA product code IWQ?
IWQ is the FDA product code for curtain, protective, radiographic. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWQ?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWQ?
Across 3 cleared submissions the average was 256 days from receipt to decision (median 112).
Which companies have the most IWQ clearances?
F. Walter Hanel GmbH (1); Hydro-Med Products, Inc. (1); Techton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWQ
- Run a recall and safety report across every IWQ manufacturer
- Watch product code IWQ 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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