FDA product code IXR: Table, Radiographic, Tilting
IXR is the FDA product code for table, radiographic, tilting. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel. FDA has cleared 77 510(k) submissions under IXR, from 41 different applicants. The average 510(k) review took 72 days (median 51). FDA has posted 26 recalls for IXR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Radiographic, Tilting |
| 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 IXR clearance
Top IXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fischer Imaging Corp. | 8 | 1996-05-03 |
| Shimadzu Medical Systems | 7 | 1992-11-27 |
| U.S. Imaging Tables, Inc. | 4 | 1997-01-30 |
| General Electric Co. | 3 | 1995-10-07 |
| Siemens Medical Solutions USA, Inc. | 3 | 1995-04-20 |
36 more applicants have IXR clearances. See the full list in Caduvo.
Most recent IXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000412 | Villa Sistemi Medicali S.P.A. | VISION R/F TILTING TABLE | 2000-04-24 | 76 |
| K973039 | GE Medical Systems | LEGACY/LEGACY-D TABLE | 1997-10-16 | 63 |
| K971128 | Jamieson Film Co. | CAP-35B III/CINE 275 | 1997-04-28 | 32 |
| K970640 | Philips Medical Systems North America, Inc. | PHILIPS EASY DIAGNOST | 1997-03-21 | 29 |
| K965105 | U.S. Imaging Tables, Inc. | ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 | 1997-01-30 | 41 |
Recalls for IXR devices
26 product recalls in 23 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-08-22.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IXR?
IXR is the FDA product code for table, radiographic, tilting. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel.
What device class is IXR?
Class II, regulation 21 CFR 892.1980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXR?
Across 77 cleared submissions the average was 72 days from receipt to decision (median 51).
Which companies have the most IXR clearances?
Fischer Imaging Corp. (8); Shimadzu Medical Systems (7); U.S. Imaging Tables, Inc. (4); General Electric Co. (3); Siemens Medical Solutions USA, Inc. (3).
Have IXR devices been recalled?
Yes: 26 product recalls across 23 recall events; the most recent began 2025-08-22.
Next steps
- Run an FDA pathway report with predicate devices for product code IXR
- Run a recall and safety report across every IXR manufacturer
- Watch product code IXR 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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