FDA product code IWY: Holder, Head, Radiographic
IWY is the FDA product code for holder, head, radiographic. It is a Class I device, regulated under 21 CFR 892.1920 and reviewed by the Radiology panel. FDA has cleared 10 510(k) submissions under IWY, from 10 different applicants. The average 510(k) review took 74 days (median 59). FDA has posted 1 recall for IWY devices.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Head, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1920 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IWY clearance
Top IWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Denar Corp. | 1 | 1992-12-28 |
| X-Ray Systems | 1 | 1989-01-12 |
| Composites Horizons, Inc. | 1 | 1989-01-09 |
| Gary E. Hall, Dds | 1 | 1987-01-07 |
| Gary D. Keller | 1 | 1985-03-22 |
5 more applicants have IWY clearances. See the full list in Caduvo.
Most recent IWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925705 | Denar Corp. | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | 1992-12-28 | 46 |
| K884493 | X-Ray Systems | HEAD HOLDING DEVICE/SLEEP APNEA | 1989-01-12 | 78 |
| K884847 | Composites Horizons, Inc. | MTD HEDREST | 1989-01-09 | 49 |
| K864527 | Gary E. Hall, Dds | DUOCEPH | 1987-01-07 | 51 |
| K850197 | Gary D. Keller | KELLER CEPHALOMETRIC DEVICE | 1985-03-22 | 63 |
Recalls for IWY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-06-05.
Frequently asked questions
What is FDA product code IWY?
IWY is the FDA product code for holder, head, radiographic. It is a Class I device, regulated under 21 CFR 892.1920 and reviewed by the Radiology panel.
What device class is IWY?
Class I, regulation 21 CFR 892.1920. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWY?
Across 10 cleared submissions the average was 74 days from receipt to decision (median 59).
Which companies have the most IWY clearances?
Denar Corp. (1); X-Ray Systems (1); Composites Horizons, Inc. (1); Gary E. Hall, Dds (1); Gary D. Keller (1).
Have IWY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code IWY
- Run a recall and safety report across every IWY manufacturer
- Watch product code IWY 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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