LEKSELL GAMMAPLAN
FDA 510(k) clearance K103093 · decided 2010-12-21
Clearance details
- K-number
- K103093
- Device name
- LEKSELL GAMMAPLAN
- Applicant
- Elekta Instrument AB
- Decision
- Substantially Equivalent
- Date received
- 2010-10-19
- Decision date
- 2010-12-21
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Stockholm, SE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Elekta Instrument AB
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 |
|---|---|---|
| Virtual Cone (1.0) (K260750) | Varian Medical Systems, Inc. | 2026-07-08 |
| RadOncAI (K253050) | Informai | 2026-06-18 |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0) (K260207) | Philips Medical Systems Nederland B.V. | 2026-05-27 |
| eXaSkin Plus (K252784) | Anatomical Geometry S.L. | 2026-05-22 |
| ART.1-US (K253078) | Seetreat Pty, Ltd. | 2026-05-14 |
| syngo.via RT Image Suite VC10 (K252304) | Varian Medical Systems, Inc. | 2026-03-18 |
| TrueFit Bolus (K260308) | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| Monaco RTP System (6.3) (K252002) | Elekta Solutions AB | 2026-02-19 |
| ART-Plan+ (v3.1.0) (K253091) | Therapanacea Sas | 2025-12-23 |
| RayStation (2024A SP3) (K252109) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| ClearCalc Model RADCA V2.6 (K252863) | Radformation, Inc. | 2025-12-19 |
| PlanOne 1 (K250963) | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Laksell GammaPlan, a computer based dose planning system specifically designed for use wit recall (Z-1719-2015) | Elekta, Inc. | 2015-06-05 |