FDA product code IXL: Device, Spot-Film
IXL is the FDA product code for device, spot-film. It is a Class II device, regulated under 21 CFR 892.1670 and reviewed by the Radiology panel. FDA has cleared 13 510(k) submissions under IXL, from 11 different applicants. The average 510(k) review took 63 days (median 53). FDA has posted 3 recalls for IXL devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Spot-Film |
| Device class | Class II |
| Regulation | 21 CFR 892.1670 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXL clearance
Top IXL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied X-Ray Technologies, Inc. | 2 | 1994-06-06 |
| Rms Div. | 2 | 1990-08-01 |
| Ge Medical Systems, LLC | 1 | 2011-07-19 |
| Fischer Imaging Corp. | 1 | 1997-03-04 |
| GE Medical Systems | 1 | 1995-02-08 |
6 more applicants have IXL clearances. See the full list in Caduvo.
Most recent IXL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111304 | Ge Medical Systems, LLC | OPTIMA XR120 | 2011-07-19 | 71 |
| K964806 | Fischer Imaging Corp. | MD-1835 | 1997-03-04 | 95 |
| K950317 | GE Medical Systems | ADVANTX 1824 SPOTFILM DEVICE | 1995-02-08 | 13 |
| K940386 | Eastman Kodak Company | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | 1994-08-17 | 203 |
| K942367 | Applied X-Ray Technologies, Inc. | AXT 1400 SPOTFILM DEVICE | 1994-06-06 | 19 |
Recalls for IXL devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-14.
Frequently asked questions
What is FDA product code IXL?
IXL is the FDA product code for device, spot-film. It is a Class II device, regulated under 21 CFR 892.1670 and reviewed by the Radiology panel.
What device class is IXL?
Class II, regulation 21 CFR 892.1670. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXL?
Across 13 cleared submissions the average was 63 days from receipt to decision (median 53).
Which companies have the most IXL clearances?
Applied X-Ray Technologies, Inc. (2); Rms Div. (2); Ge Medical Systems, LLC (1); Fischer Imaging Corp. (1); GE Medical Systems (1).
Have IXL devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2010-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code IXL
- Run a recall and safety report across every IXL manufacturer
- Watch product code IXL 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times