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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
NEMA PS 3.1 - 3.20 (2016)
Digital Imaging and Communications in Medicine (DICOM) Set
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FDA recognition of DICOM PS 3.1-3.20 (2016) [Rec# 12-300] will be superseded by recognition of DICOM PS 3.1 - 3.20 2021e [Rec# 12-341].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
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.