IYW — Scanner, Rectilinear, Nuclear Class I
FDA product code IYW covers "Scanner, Rectilinear, Nuclear", a Class I medical device regulated under 21 CFR 892.1300. Submissions are reviewed by the Radiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IYW
- Device Class
- Class I
- Regulation Number
- 892.1300
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K944684 | mse medizintechnik gmbh and co. kg | POLYSCAN DIGITAL SCANNER | May 15, 1995 |
| K895799 | atomic products | RECTILINEAR SCANNER MODEL #187-270 | February 1, 1990 |
| K882453 | medical and scientific enterprises | POLYSCAN DIGITAL SCANNER | November 23, 1988 |
| K780395 | union carbide | IMAGER, BODY SECTION, RADIONUCLIDE | March 31, 1978 |