INTEGRITY(TM)
FDA 510(k) clearance K112613 · decided 2011-12-16
Clearance details
- K-number
- K112613
- Device name
- INTEGRITY(TM)
- Applicant
- Elekta Limited
- Decision
- Substantially Equivalent
- Date received
- 2011-09-07
- Decision date
- 2011-12-16
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Crawley, West Sussex, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integrity 1.1. Integrity is the interface and control software for the Elekta range of med recall (Z-1322-2014) | Elekta, Inc. | 2014-04-02 |
| Integrity. Version 1.1 of the Integrity interface and control software for the Elekta rang recall (Z-1083-2014) | Elekta, Inc. | 2014-03-06 |