FDA product code KXJ: Table, Radiologic
KXJ is the FDA product code for table, radiologic. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel. FDA has cleared 31 510(k) submissions under KXJ, from 26 different applicants. The average 510(k) review took 54 days (median 42). FDA has posted 27 recalls for KXJ devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Radiologic |
| 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 KXJ clearance
Top KXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Corp. | 3 | 1982-02-18 |
| Continental X-Ray Corp. | 2 | 1993-06-14 |
| Radkor, Inc. | 2 | 1988-10-19 |
| Philips Medical Systems (Cleveland), Inc. | 2 | 1986-01-28 |
| Villa Sistemi Medicali S.P.A. | 1 | 2005-03-25 |
21 more applicants have KXJ clearances. See the full list in Caduvo.
Most recent KXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050190 | Villa Sistemi Medicali S.P.A. | APOLLO | 2005-03-25 | 57 |
| K963905 | X-Ray Technologies, Inc. | RADIOGRAPHIC ITT TABLE | 1996-11-12 | 43 |
| K955414 | Wuestec Medical, Inc. | XRT 400 | 1996-07-24 | 240 |
| K951146 | Septa Corp. | IMAGING TABLE | 1995-05-04 | 52 |
| K950068 | Medtec, Inc. | CARBON FIBER COUCH INSERT | 1995-04-06 | 87 |
Recalls for KXJ devices
27 product recalls in 12 recall events; 6 initiated in the last five years and 14 still open. Most recent: 2026-08-06.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 5 |
| 2021 | 3 |
| 2025 | 5 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KXJ?
KXJ is the FDA product code for table, radiologic. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel.
What device class is KXJ?
Class II, regulation 21 CFR 892.1980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KXJ?
Across 31 cleared submissions the average was 54 days from receipt to decision (median 42).
Which companies have the most KXJ clearances?
Siemens Corp. (3); Continental X-Ray Corp. (2); Radkor, Inc. (2); Philips Medical Systems (Cleveland), Inc. (2); Villa Sistemi Medicali S.P.A. (1).
Have KXJ devices been recalled?
Yes: 27 product recalls across 12 recall events; the most recent began 2026-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code KXJ
- Run a recall and safety report across every KXJ manufacturer
- Watch product code KXJ 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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