XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
FDA 510(k) clearance K122951 · decided 2013-01-17
Clearance details
- K-number
- K122951
- Device name
- XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
- Applicant
- Icad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-25
- Decision date
- 2013-01-17
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Nashua, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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|---|---|---|
| PowerLook® Tomo Detection Software (P160009) | Icad, Inc. | 2017-03-24 |
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| M-VU ALGORITHM ENGINE (P100005/S004) | Icad, Inc. | 2014-06-06 |
| M-VU ALGORITHM ENGINE (P100005/S003) | Icad, Inc. | 2013-12-02 |
| M-VU ALGORITHM ENGINE (P100005/S002) | Icad, Inc. | 2013-06-19 |
| SECONDLOOK DIGITAL (P010038/S017) | Icad, Inc. | 2013-06-19 |
| SECONDLOOK DIGITAL V7.2 CAD (P010038/S016) | Icad, Inc. | 2012-11-09 |