FDA product code IYZ: Bed, Scanning, Nuclear
IYZ is the FDA product code for bed, scanning, nuclear. It is a Class I device, regulated under 21 CFR 892.1350 and reviewed by the Radiology panel. FDA has cleared 12 510(k) submissions under IYZ, from 5 different applicants. The average 510(k) review took 67 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Bed, Scanning, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1350 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IYZ clearance
Top IYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Tron Products, Inc. | 6 | 1991-08-09 |
| Siemens Gammasonics, Inc. | 3 | 1991-08-02 |
| Nu Age Products | 1 | 1992-04-17 |
| Atomic Products Corp. | 1 | 1992-01-17 |
| Qrsystems, Inc. | 1 | 1989-08-02 |
Most recent IYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920962 | Nu Age Products | MULTIPLE ACCESSORY TO GAMMA CAMERAS | 1992-04-17 | 74 |
| K915541 | Atomic Products Corp. | SPECT TABLE, MODEL #056-760 | 1992-01-17 | 38 |
| K911691 | Med-Tron Products, Inc. | XYZ CRANK IMAGING TABLE | 1991-08-09 | 115 |
| K912481 | Siemens Gammasonics, Inc. | ECT CARBON FIBER PALLET, MODIFICATION | 1991-08-02 | 71 |
| K912286 | Siemens Gammasonics, Inc. | CARDIAC SPECT PALLET | 1991-08-02 | 71 |
Recalls for IYZ devices
openFDA lists no recalls for product code IYZ.
Frequently asked questions
What is FDA product code IYZ?
IYZ is the FDA product code for bed, scanning, nuclear. It is a Class I device, regulated under 21 CFR 892.1350 and reviewed by the Radiology panel.
What device class is IYZ?
Class I, regulation 21 CFR 892.1350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IYZ?
Across 12 cleared submissions the average was 67 days from receipt to decision (median 70).
Which companies have the most IYZ clearances?
Med-Tron Products, Inc. (6); Siemens Gammasonics, Inc. (3); Nu Age Products (1); Atomic Products Corp. (1); Qrsystems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYZ
- Run a recall and safety report across every IYZ manufacturer
- Watch product code IYZ 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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