FDA product code IXQ: Table, Radiographic, Stationary Top
IXQ is the FDA product code for table, radiographic, stationary top. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel. FDA has cleared 27 510(k) submissions under IXQ, from 22 different applicants. The average 510(k) review took 96 days (median 64). FDA has posted 7 recalls for IXQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Radiographic, Stationary Top |
| Device class | Class II |
| Regulation | 21 CFR 892.1980 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXQ clearance
Top IXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtec, Inc. | 2 | 1997-12-05 |
| Continental X-Ray Corp. | 2 | 1991-10-10 |
| Atomic Products Corp. | 2 | 1990-11-29 |
| Garrels X-Ray Products, Inc. | 2 | 1986-09-04 |
| Tecnomed, Inc. | 2 | 1978-07-17 |
17 more applicants have IXQ clearances. See the full list in Caduvo.
Most recent IXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973842 | Medtec, Inc. | CARBON FIBER CONFORMAL COUCH TOP | 1997-12-05 | 58 |
| K960083 | Wuestec Medical, Inc. | MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 | 1996-07-24 | 195 |
| K954225 | Medtec, Inc. | MED-TEC HAND GRIP | 1995-11-14 | 64 |
| K946262 | Scott Imaging Intl., Inc. | EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES | 1995-02-15 | 64 |
| K942916 | Octostop, Inc. | OCTOPAQUE UNIVERSAL | 1994-09-08 | 79 |
Recalls for IXQ devices
7 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-30.
Frequently asked questions
What is FDA product code IXQ?
IXQ is the FDA product code for table, radiographic, stationary top. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel.
What device class is IXQ?
Class II, regulation 21 CFR 892.1980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXQ?
Across 27 cleared submissions the average was 96 days from receipt to decision (median 64).
Which companies have the most IXQ clearances?
Medtec, Inc. (2); Continental X-Ray Corp. (2); Atomic Products Corp. (2); Garrels X-Ray Products, Inc. (2); Tecnomed, Inc. (2).
Have IXQ devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2010-12-30.
Next steps
- Run an FDA pathway report with predicate devices for product code IXQ
- Run a recall and safety report across every IXQ manufacturer
- Watch product code IXQ 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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