FDA product code IXJ: Grid, Radiographic
IXJ is the FDA product code for grid, radiographic. It is a Class I device, regulated under 21 CFR 892.1910 and reviewed by the Radiology panel. FDA has cleared 15 510(k) submissions under IXJ, from 15 different applicants. The average 510(k) review took 87 days (median 80). FDA has posted 1 recall for IXJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Grid, Radiographic |
| Device class | Class I |
| Regulation | 21 CFR 892.1910 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXJ clearance
Top IXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| X-Ray Accessory Corp. | 1 | 1997-06-13 |
| Smit Rontgen | 1 | 1996-11-07 |
| Unidex Group, Inc. | 1 | 1996-07-03 |
| Thermotrex Corp. | 1 | 1996-02-02 |
| Seibu Techno Coproration | 1 | 1995-01-31 |
10 more applicants have IXJ clearances. See the full list in Caduvo.
Most recent IXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964025 | X-Ray Accessory Corp. | MITAYA ALUMINUM INTERSPACED X-RAY GRID | 1997-06-13 | 249 |
| K963893 | Smit Rontgen | FIBRE INTERSPACED X-RAY GRID | 1996-11-07 | 41 |
| K962338 | Unidex Group, Inc. | RADIOGRAPHIC GRID | 1996-07-03 | 16 |
| K954294 | Thermotrex Corp. | HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES | 1996-02-02 | 141 |
| K945697 | Seibu Techno Coproration | SK S-RAY GRIDS | 1995-01-31 | 75 |
Recalls for IXJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-04-08.
Frequently asked questions
What is FDA product code IXJ?
IXJ is the FDA product code for grid, radiographic. It is a Class I device, regulated under 21 CFR 892.1910 and reviewed by the Radiology panel.
What device class is IXJ?
Class I, regulation 21 CFR 892.1910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXJ?
Across 15 cleared submissions the average was 87 days from receipt to decision (median 80).
Which companies have the most IXJ clearances?
X-Ray Accessory Corp. (1); Smit Rontgen (1); Unidex Group, Inc. (1); Thermotrex Corp. (1); Seibu Techno Coproration (1).
Have IXJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code IXJ
- Run a recall and safety report across every IXJ manufacturer
- Watch product code IXJ 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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