FDA product code IZZ: Table, Radiographic, Non-Tilting, Powered
IZZ is the FDA product code for table, radiographic, non-tilting, powered. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel. FDA has cleared 29 510(k) submissions under IZZ, from 22 different applicants. The average 510(k) review took 62 days (median 45). FDA has posted 19 recalls for IZZ devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Radiographic, Non-Tilting, Powered |
| 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 IZZ clearance
Top IZZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shimadzu Medical Systems | 3 | 1995-05-11 |
| Continental X-Ray Corp. | 3 | 1991-11-19 |
| General Electric Co. | 3 | 1988-12-22 |
| Toshiba America Medical Systems, In.C | 2 | 1995-04-06 |
| Siemens Medical Solutions USA, Inc. | 1 | 1997-05-14 |
17 more applicants have IZZ clearances. See the full list in Caduvo.
Most recent IZZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971452 | Siemens Medical Solutions USA, Inc. | MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE | 1997-05-14 | 23 |
| K952701 | Med-Tron Products, Inc. | MED-TRON SPECT IMAGING TABLE | 1995-07-06 | 23 |
| K951315 | Shimadzu Medical Systems | CATHETERIZATION TABLE KS-60 | 1995-05-11 | 49 |
| K951053 | Toshiba America Medical Systems, In.C | ANGIOREX CAT-350B | 1995-04-06 | 30 |
| K943926 | Philips Medical Systems (Cleveland), Inc. | RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE | 1994-11-28 | 108 |
Recalls for IZZ devices
19 product recalls in 7 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2024-05-31.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
| 2024 | 9 |
Frequently asked questions
What is FDA product code IZZ?
IZZ is the FDA product code for table, radiographic, non-tilting, powered. It is a Class II device, regulated under 21 CFR 892.1980 and reviewed by the Radiology panel.
What device class is IZZ?
Class II, regulation 21 CFR 892.1980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZZ?
Across 29 cleared submissions the average was 62 days from receipt to decision (median 45).
Which companies have the most IZZ clearances?
Shimadzu Medical Systems (3); Continental X-Ray Corp. (3); General Electric Co. (3); Toshiba America Medical Systems, In.C (2); Siemens Medical Solutions USA, Inc. (1).
Have IZZ devices been recalled?
Yes: 19 product recalls across 7 recall events; the most recent began 2024-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code IZZ
- Run a recall and safety report across every IZZ manufacturer
- Watch product code IZZ 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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