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FDA 510(k), K141069, Lung Density Analysis
FDA 510(k), K141069, Lung Density Analysis
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510(K) Number: K141069
Device Name: Lung Density Analysis
Manufacturer: IMBIO LLC
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 04/24/2014
Decision Date: 09/17/2014
Regulation Medical Specialty: Radiology
Device Name: Lung Density Analysis
Manufacturer: IMBIO LLC
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 04/24/2014
Decision Date: 09/17/2014
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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