The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Calypso System.
| Device ID | K123137 |
| 510k Number | K123137 |
| Device Name: | CALYPSO SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS 2101 FORTH AVE, SUITE 500 Seattle, WA 98121 |
| Contact | Marcia Page |
| Correspondent | Marcia Page VARIAN MEDICAL SYSTEMS 2101 FORTH AVE, SUITE 500 Seattle, WA 98121 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011006115 | K123137 | 000 |