GAMMAPLAN
FDA 510(k) clearance K051022 · decided 2005-06-01
Clearance details
- K-number
- K051022
- Device name
- GAMMAPLAN
- Applicant
- Elekta Instrument AB
- Decision
- Substantially Equivalent
- Date received
- 2005-04-22
- Decision date
- 2005-06-01
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- IWB
- Device class
- 2
- Regulation number
- 892.5750
- 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 |
|---|---|---|
| Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (K250391) | Elekta Solutions AB | 2025-07-02 |
| Leksell GammaPlan (LGP) (K232854) | Elekta Solutions AB | 2024-02-08 |
| Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (K222047) | Elekta Solutions AB | 2022-10-26 |
| TaiChiC (K203250) | Our United Corporation | 2021-03-12 |
| Akesis Galaxy RTi (K203146) | Akesis, Inc. | 2021-03-05 |
| Akesis Galaxy RTx (K200050) | Akesis, Inc. | 2020-02-04 |
| Akesis Galaxy (K190844) | Akesis, Inc. | 2019-09-04 |
| GammaPod (K180571) | Xcision Medical Systems, LLC | 2018-04-04 |
| Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (K173789) | Elekta Instrument AB | 2018-03-30 |
| Leksell GammaPlan (K173791) | Elekta Instrument AB | 2018-02-09 |
| GammaPod - Model A (K172706) | Xcision Medical Systems, LLC | 2017-12-22 |
| Leksell Gamma Knife Icon (K160440) | Elekta Instrument AB | 2016-04-20 |
Recalls involving this device
No recalls on record reference this clearance.