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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 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
Transition Period
FDA recognition of DICOM PS 3.1-3.20 (2016) [Rec# 12-300] will be superseded by recognition of DICOM PS 3.1 - 3.20 2021e [Rec# 12-341]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-300] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 12-300] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.2050 System, Image Processing, Radiological Class 2 LLZ
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System. Issued March 2012.

Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology. Issued October 2017.

FDA Technical Contact
 Daniel Krainak
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  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
*These are provided as examples and others may be applicable.
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