The following data is part of a premarket notification filed by Elekta, Inc with the FDA for Mosaiq Oncology Information System.
| Device ID | K183034 |
| 510k Number | K183034 |
| Device Name: | MOSAIQ Oncology Information System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta, Inc 100 Mathilda Place 5th Floor Sunnyvale, CA 94086 |
| Contact | Faiza Ahmed |
| Correspondent | Faiza Ahmed Elekta, Inc 100 Mathilda Place 5th Floor Sunnyvale, CA 94086 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2018-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858164002251 | K183034 | 000 |
| 00858164002367 | K183034 | 000 |
| 00858164002336 | K183034 | 000 |
| 00858164002282 | K183034 | 000 |