The following data is part of a premarket notification filed by Med-tron Products, Inc. with the FDA for Xy Imaging Table.
| Device ID | K912135 |
| 510k Number | K912135 |
| Device Name: | XY IMAGING TABLE |
| Classification | Bed, Scanning, Nuclear |
| Applicant | MED-TRON PRODUCTS, INC. P.O. BOX 866 Miller Place, NY 11764 |
| Contact | Katherine Maguill |
| Correspondent | Katherine Maguill MED-TRON PRODUCTS, INC. P.O. BOX 866 Miller Place, NY 11764 |
| Product Code | IYZ |
| CFR Regulation Number | 892.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-07-17 |