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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 12-300
Standard
NEMA PS 3.1 - 3.20 (2016)
Digital Imaging and Communications in Medicine (DICOM) Set
Scope/Abstract
Provides an overview of the entire Digital Imaging and Communications in Medicine (DICOM) standard. Describes the history, scope, goals, and structure of the standard. Contains a brief description of the contents of each part of the standard.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§892.2050 System, Image Processing, Radiological Class 2 LLZ
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry: Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073720.htm

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System. Document issued on: November 5, 2010
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107552.htm

Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions. Document issued on: May 30, 2008
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107549.htm
FDA Technical Contact
 Daniel Krainak
  FDA/OMPT/CDRH/OIR/DRH/MREP/
  301-796-0478
  Daniel.Krainak@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
Radiology
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