FDA product code IZS: Aperture, Radiographic
IZS is the FDA product code for aperture, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IZS. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Aperture, Radiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1610 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IZS clearance
Top IZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Custom Medical Products, Ltd. | 1 | 1989-10-27 |
Most recent IZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895084 | Custom Medical Products, Ltd. | APERTURE | 1989-10-27 | 74 |
Recalls for IZS devices
openFDA lists no recalls for product code IZS.
Frequently asked questions
What is FDA product code IZS?
IZS is the FDA product code for aperture, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel.
What device class is IZS?
Class II, regulation 21 CFR 892.1610. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZS?
Across 1 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most IZS clearances?
Custom Medical Products, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IZS
- Run a recall and safety report across every IZS manufacturer
- Watch product code IZS 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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