The following data is part of a premarket notification filed by Scanditronix, Inc. with the FDA for Mm-22 Microtron, Mm50 Microtron.
| Device ID | K900434 |
| 510k Number | K900434 |
| Device Name: | MM-22 MICROTRON, MM50 MICROTRON |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDITRONIX, INC. 106 WESTERN AVE. POST OFFICE BOX 987 Essex, MA 01929 |
| Contact | Roy M Emanuelson |
| Correspondent | Roy M Emanuelson SCANDITRONIX, INC. 106 WESTERN AVE. POST OFFICE BOX 987 Essex, MA 01929 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-10-23 |