| Device Classification Name |
solid state x-ray imager (flat panel/digital imager) |
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|---|---|---|---|---|
| 510(k) Number | K122182 | |||
| Device Name | DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC | |||
| Applicant |
|
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| Applicant Contact | dave kim | |||
| Correspondent |
|
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| Correspodent Contact | dave kim | |||
| Regulation Number | 892.1680 | |||
| Classification Product Code |
|
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| Date Received | 07/23/2012 | |||
| Decision Date | 08/16/2012 | |||
| 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 | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |