FDA product code IYW: Scanner, Rectilinear, Nuclear
IYW is the FDA product code for scanner, rectilinear, nuclear. It is a Class I device, regulated under 21 CFR 892.1300 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under IYW, from 4 different applicants. The average 510(k) review took 135 days (median 144).
Classification
| Field | Value |
|---|---|
| Device name | Scanner, Rectilinear, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1300 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IYW clearance
Top IYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mse Medizintechnik GmbH & Co. KG | 1 | 1995-05-15 |
| Atomic Products Corp. | 1 | 1990-02-01 |
| Medical and Scientific Enterprises, Inc. | 1 | 1988-11-23 |
| Union Carbide Corp. | 1 | 1978-03-31 |
Most recent IYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944684 | Mse Medizintechnik GmbH & Co. KG | POLYSCAN DIGITAL SCANNER | 1995-05-15 | 235 |
| K895799 | Atomic Products Corp. | RECTILINEAR SCANNER MODEL #187-270 | 1990-02-01 | 126 |
| K882453 | Medical and Scientific Enterprises, Inc. | POLYSCAN DIGITAL SCANNER | 1988-11-23 | 162 |
| K780395 | Union Carbide Corp. | IMAGER, BODY SECTION, RADIONUCLIDE | 1978-03-31 | 18 |
Recalls for IYW devices
openFDA lists no recalls for product code IYW.
Frequently asked questions
What is FDA product code IYW?
IYW is the FDA product code for scanner, rectilinear, nuclear. It is a Class I device, regulated under 21 CFR 892.1300 and reviewed by the Radiology panel.
What device class is IYW?
Class I, regulation 21 CFR 892.1300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IYW?
Across 4 cleared submissions the average was 135 days from receipt to decision (median 144).
Which companies have the most IYW clearances?
Mse Medizintechnik GmbH & Co. KG (1); Atomic Products Corp. (1); Medical and Scientific Enterprises, Inc. (1); Union Carbide Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYW
- Run a recall and safety report across every IYW manufacturer
- Watch product code IYW 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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