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U.S. Department of Health and Human Services

Product Classification

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Device lung computed tomography system, computer-aided detection
Regulation Description Picture archiving and communications system.
Definition To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review.A computer aided diagnosis, lung computed tomography system is a class 3 device under product code nrr.
Physical State Software device.
Technical Method Detection algorithm searches for and identifies potential nodules on images of the chest acquired using multi-slice computed tomography (msct).
Target Area Lung
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOEB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187249.htm] 
Third Party Review Not Third Party Eligible
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