The following data is part of a premarket notification filed by Scanditronix Medical Ab with the FDA for Invidos.
| Device ID | K002051 |
| 510k Number | K002051 |
| Device Name: | INVIDOS |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDITRONIX MEDICAL AB STALGATAN 14 Uppsala S-754 50, SE S-754 50 |
| Contact | Eva Larsten |
| Correspondent | Eva Larsten SCANDITRONIX MEDICAL AB STALGATAN 14 Uppsala S-754 50, SE S-754 50 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-06 |
| Decision Date | 2000-09-05 |