| Device Classification Name |
system, imaging, pulsed echo, ultrasonic |
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|---|---|---|---|---|
| 510(k) Number | K131489 | |||
| Device Name | TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION | |||
| Applicant |
|
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| Applicant Contact | mark job | |||
| Regulation Number | 892.1560 | |||
| Classification Product Code |
|
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| Date Received | 05/23/2013 | |||
| Decision Date | 06/25/2013 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Radiology |
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| 510k Review Panel |
Radiology |
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| summary |
summary |
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| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |