FDA product code IXW: Processor, Radiographic-Film, Automatic
IXW is the FDA product code for processor, radiographic-film, automatic. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel. FDA has cleared 83 510(k) submissions under IXW, from 29 different applicants. The average 510(k) review took 89 days (median 59). FDA has posted 1 recall for IXW devices.
Classification
| Field | Value |
|---|---|
| Device name | Processor, Radiographic-Film, Automatic |
| Device class | Class II |
| Regulation | 21 CFR 892.1900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXW clearance
Top IXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 31 | 1997-01-27 |
| Konica Medical Corp. | 7 | 1999-06-18 |
| Alphatek Corp. | 5 | 2003-01-23 |
| Fujifilm Medical System U.S.A., Inc. | 4 | 1995-10-27 |
| 3M Company | 4 | 1994-03-22 |
24 more applicants have IXW clearances. See the full list in Caduvo.
Most recent IXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111167 | Velopex International, Inc. | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | 2011-08-18 | 114 |
| K093503 | Velopex International, Inc. | INTRAX FILM PROCESSOR | 2010-01-06 | 55 |
| K091628 | Protec GmbH & Co. KG | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX | 2009-08-21 | 78 |
| K024342 | Daito Co., Ltd. | RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 | 2003-04-23 | 117 |
| K023801 | S.A.I.E.P. S.R.L. | FILM PROCESSOR, MODEL LIFE RAY PRO 1000 | 2003-02-12 | 90 |
Recalls for IXW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-01.
Frequently asked questions
What is FDA product code IXW?
IXW is the FDA product code for processor, radiographic-film, automatic. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel.
What device class is IXW?
Class II, regulation 21 CFR 892.1900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXW?
Across 83 cleared submissions the average was 89 days from receipt to decision (median 59).
Which companies have the most IXW clearances?
Eastman Kodak Company (31); Konica Medical Corp. (7); Alphatek Corp. (5); Fujifilm Medical System U.S.A., Inc. (4); 3M Company (4).
Have IXW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code IXW
- Run a recall and safety report across every IXW manufacturer
- Watch product code IXW 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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