The following data is part of a premarket notification filed by Elekta Oncology Systems, Ltd. with the FDA for Elekta Synergy System.
| Device ID | K032996 |
| 510k Number | K032996 |
| Device Name: | ELEKTA SYNERGY SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA ONCOLOGY SYSTEMS, LTD. 4775 PEACHTREE INDUSTRIAL BLVD BLDG 300, SUITE 300 Norcross, GA 30092 |
| Contact | Peter Stegagno |
| Correspondent | Peter Stegagno ELEKTA ONCOLOGY SYSTEMS, LTD. 4775 PEACHTREE INDUSTRIAL BLVD BLDG 300, SUITE 300 Norcross, GA 30092 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2003-10-23 |
| Summary: | summary |