The following data is part of a premarket notification filed by Scanditronix, Inc. with the FDA for Scandiplan - Version 338.
| Device ID | K914926 |
| 510k Number | K914926 |
| Device Name: | SCANDIPLAN - VERSION 338 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | SCANDITRONIX, INC. 106 WESTERN AVE. POST OFFICE BOX 987 Essex, MA 01929 |
| Contact | Roy Emanuelson |
| Correspondent | Roy Emanuelson SCANDITRONIX, INC. 106 WESTERN AVE. POST OFFICE BOX 987 Essex, MA 01929 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-05-28 |