HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
FDA 510(k) clearance K131777 · decided 2014-02-28
Clearance details
- K-number
- K131777
- Device name
- HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
- Applicant
- Hyper Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-17
- Decision date
- 2014-02-28
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- IWB
- Device class
- 2
- Regulation number
- 892.5750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| 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.