FDA product code IXC: Illuminator, Radiographic-Film
IXC is the FDA product code for illuminator, radiographic-film. It is a Class I device, regulated under 21 CFR 892.1890 and reviewed by the Radiology panel. FDA has cleared 18 510(k) submissions under IXC, from 16 different applicants. The average 510(k) review took 42 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Illuminator, Radiographic-Film |
| Device class | Class I |
| Regulation | 21 CFR 892.1890 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXC clearance
Top IXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Western Electronics, Inc. | 3 | 1980-10-23 |
| Smartlight, Inc. | 1 | 1999-06-01 |
| Smartlight, Ltd. | 1 | 1997-12-12 |
| Arnold & Richter Cine Technik | 1 | 1997-09-02 |
| Focused Viewer, Inc. | 1 | 1997-03-11 |
11 more applicants have IXC clearances. See the full list in Caduvo.
Most recent IXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991302 | Smartlight, Inc. | SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS | 1999-06-01 | 46 |
| K973965 | Smartlight, Ltd. | SMART MOTORIZED VIEWER | 1997-12-12 | 56 |
| K973115 | Arnold & Richter Cine Technik | ARRIPRO 35 ST/TV | 1997-09-02 | 13 |
| K970240 | Focused Viewer, Inc. | DIFFUSER PANEL | 1997-03-11 | 48 |
| K954998 | Lily Imaging Solutions Co. | LILY DARK VIEWER | 1996-01-29 | 89 |
Recalls for IXC devices
openFDA lists no recalls for product code IXC.
Frequently asked questions
What is FDA product code IXC?
IXC is the FDA product code for illuminator, radiographic-film. It is a Class I device, regulated under 21 CFR 892.1890 and reviewed by the Radiology panel.
What device class is IXC?
Class I, regulation 21 CFR 892.1890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXC?
Across 18 cleared submissions the average was 42 days from receipt to decision (median 41).
Which companies have the most IXC clearances?
Med-Western Electronics, Inc. (3); Smartlight, Inc. (1); Smartlight, Ltd. (1); Arnold & Richter Cine Technik (1); Focused Viewer, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IXC
- Run a recall and safety report across every IXC manufacturer
- Watch product code IXC 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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