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FDA 510(k), K153331, SafeCT-29
FDA 510(k), K153331, SafeCT-29
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510(K) Number: K153331
Device Name: SafeCT-29
Manufacturer: MEDIC VISION IMAGING SOLUTIONS
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 11/19/2015
Decision Date: 05/17/2016
Regulation Medical Specialty: Radiology
Device Name: SafeCT-29
Manufacturer: MEDIC VISION IMAGING SOLUTIONS
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 11/19/2015
Decision Date: 05/17/2016
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
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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