FDA product code IXH: Camera, Focal Spot, Radiographic
IXH is the FDA product code for camera, focal spot, radiographic. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under IXH, from 2 different applicants. The average 510(k) review took 40 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Camera, Focal Spot, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1940 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IXH clearance
Top IXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mbf Sales, LLC | 1 | 2002-11-26 |
| Victoreen, Inc. | 1 | 1985-05-28 |
Most recent IXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023390 | Mbf Sales, LLC | MY BREAST FRIEND, BREAST SELF-EXAM PAD | 2002-11-26 | 48 |
| K851811 | Victoreen, Inc. | SLIT CAMERA MODEL 07-624 | 1985-05-28 | 32 |
Recalls for IXH devices
openFDA lists no recalls for product code IXH.
Frequently asked questions
What is FDA product code IXH?
IXH is the FDA product code for camera, focal spot, radiographic. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel.
What device class is IXH?
Class I, regulation 21 CFR 892.1940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXH?
Across 2 cleared submissions the average was 40 days from receipt to decision (median 40).
Which companies have the most IXH clearances?
Mbf Sales, LLC (1); Victoreen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXH
- Run a recall and safety report across every IXH manufacturer
- Watch product code IXH 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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