The following data is part of a premarket notification filed by Elekta, Inc with the FDA for Elekta Synergy; Elekta Synergy S And Xvir3.5.
| Device ID | K051932 |
| 510k Number | K051932 |
| Device Name: | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA, INC 4775 PEACHTREE IND. BLVD BUILDING 300, SUITE 300 Norcross, GA 30092 |
| Contact | Peter Stegagno |
| Correspondent | Peter Stegagno ELEKTA, INC 4775 PEACHTREE IND. BLVD BUILDING 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 | 2005-07-13 |
| Decision Date | 2005-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071017 | K051932 | 000 |
| 05060191070904 | K051932 | 000 |
| 05060191070898 | K051932 | 000 |
| 05060191070881 | K051932 | 000 |
| 05060191070874 | K051932 | 000 |
| 05060191070867 | K051932 | 000 |
| 05060191070850 | K051932 | 000 |
| 05060191070843 | K051932 | 000 |
| 05060191070836 | K051932 | 000 |
| 05060191070911 | K051932 | 000 |
| 05060191070928 | K051932 | 000 |
| 05060191071000 | K051932 | 000 |
| 05060191070997 | K051932 | 000 |
| 05060191070980 | K051932 | 000 |
| 05060191070973 | K051932 | 000 |
| 05060191070966 | K051932 | 000 |
| 05060191070959 | K051932 | 000 |
| 05060191070942 | K051932 | 000 |
| 05060191070935 | K051932 | 000 |
| 05060191070829 | K051932 | 000 |