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U.S. Department of Health and Human Services

Product Classification

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Device system, tomographic, nuclear
Regulation Description Nuclear tomography system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeJWM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final
Third Party Review
Accredited Persons

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