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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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