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FDA 510(k), K042694, ADVANCED LUNG ANALYSIS II
FDA 510(k), K042694, ADVANCED LUNG ANALYSIS II
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510(K) Number: K042694
Device Name: ADVANCED LUNG ANALYSIS II
Manufacturer: GE MEDICAL SYSTEMS
Device Classification Name: lung computed tomography system, computer-aided detection
Regulation Number: 892.2050
Classification Product Code: OEB
Date Received: 09/30/2004
Decision Date: 11/18/2004
Regulation Medical Specialty: Radiology
Device Name: ADVANCED LUNG ANALYSIS II
Manufacturer: GE MEDICAL SYSTEMS
Device Classification Name: lung computed tomography system, computer-aided detection
Regulation Number: 892.2050
Classification Product Code: OEB
Date Received: 09/30/2004
Decision Date: 11/18/2004
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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