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FDA 510(k), K160371, NovaPACS
FDA 510(k), K160371, NovaPACS
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510(K) Number: K160371
Device Name: NovaPACS
Manufacturer: NOVARAD CORPORATION
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 02/10/2016
Decision Date: 10/14/2016
Regulation Medical Specialty: Radiology
Device Name: NovaPACS
Manufacturer: NOVARAD CORPORATION
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 02/10/2016
Decision Date: 10/14/2016
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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