ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
FDA 510(k) clearance K051932 · decided 2005-08-12
Clearance details
- K-number
- K051932
- Device name
- ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
- Applicant
- Elekta, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-13
- Decision date
- 2005-08-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Elekta
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Halcyon, Ethos Radiotherapy System (5.0) (K261856) | Varian Medical Systems, Inc. | 2026-08-03 |
| ThinkQA 3 (K252937) | Dosisoft SA | 2026-06-12 |
| LUNA 3D (K253004) | Lap GmbH Laser Applikationen | 2026-06-04 |
| AerFrame Patient Immobilization System (AFPIS) (K260792) | Stabilix, LLC | 2026-05-08 |
| VERIQA RT EPID 3D (K252258) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 |
| ClearCheck (RADCC V2.7) (K253962) | Radformation, Inc. | 2026-04-03 |
| AlignRT Plus (8.0) (K253012) | Vision Rt, Ltd. | 2026-03-18 |
| Halcyon, Ethos Radiotherapy System (5.0) (K252977) | Varian Medical Systems, Inc. | 2026-01-21 |
| EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188) | Elekta Solutions AB | 2026-01-15 |
| ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010) | Brainlab SE | 2026-01-14 |
| ChartCheck (RADCH V1.6) (K252988) | Radformation, Inc. | 2026-01-05 |
| IDENTIFY (5.0) (K252919) | Varian Medical Systems, Inc. | 2025-12-16 |