The following data is part of a premarket notification filed by Elekta Solutions Ab with the FDA for Mosaiq Oncology Information System.
| Device ID | K203172 |
| 510k Number | K203172 |
| Device Name: | MOSAIQ Oncology Information System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Solutions AB Kungstensgatan 18, Box 7593 Stockholm, SE Se-10393 |
| Contact | Melinda Smith |
| Correspondent | Thomas Valentine Elekta, Inc. 400 Perimeter Center Terrance NE, Suite 50 Atlanta, GA 30346 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-26 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340201500026 | K203172 | 000 |