The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Imager, Body Section, Radionuclide.
| Device ID | K780395 |
| 510k Number | K780395 |
| Device Name: | IMAGER, BODY SECTION, RADIONUCLIDE |
| Classification | Scanner, Rectilinear, Nuclear |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYW |
| CFR Regulation Number | 892.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-13 |
| Decision Date | 1978-03-31 |