Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
FDA 510(k) clearance K210500 · decided 2021-06-11
Clearance details
- K-number
- K210500
- Device name
- Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
- Applicant
- Elekta Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-02-22
- Decision date
- 2021-06-11
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Crawley, GB
- Third-party review
- No
- Expedited review
- No
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