• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 061 Date of Entry 12/18/2023 
FR Recognition Number 12-352
Standard
NEMA  PS 3.1 - 3.20 2023e
Digital Imaging and Communications in Medicine (DICOM) Set
Scope/Abstract
Digital Imaging and Communications in Medicine (DICOM) is the standard for the communication and management of medical imaging information and related data.

The DICOM Standard facilitates interoperability of medical imaging equipment by specifying:

For network communications, a set of protocols to be followed by devices claiming conformance to the Standard.

The syntax and semantics of Commands and associated information that can be exchanged using these protocols.

For media communication, a set of media storage services to be followed by devices claiming conformance to the Standard, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media.

Information that must be supplied with an implementation for which conformance to the Standard is claimed.

The DICOM Standard does not specify:

The implementation details of any features of the Standard on a device claiming conformance.

The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICOM conformance.

A testing/validation procedure to assess an implementation's conformance to the Standard.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of NEMA PS 3.1 - 3.20 2022d [Rec# 12-349] will be superseded by recognition of NEMA PS 3.1 - 3.20 2023e [Rec# 12-352]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-349] until December 22, 2024. After this transition period, declarations of conformity to [Rec# 12-349] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.3700 Digital Pathology Image Viewing And Management Software Class 2 QKQ
§864.3750 Software Algorithm Device To Assist Users In Digital Pathology Class 2 QPN
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
§886.1570 Ophthalmoscope, Laser, Scanning Class 2 MYC
§886.1570 Tomography, Optical Coherence Class 2 OBO
§886.1850 Biomicroscope, Slit-Lamp, Ac-Powered Class 2 HJO
§886.1850 Device, Analysis, Anterior Segment Class 2 MXK
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
§892.2050 System, Image Processing, Radiological Class 2 LLZ
§892.2050 System, Image Management, Ophthalmic Class 2 NFJ
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Daniel Krainak
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-0478
  Daniel.Krainak@fda.hhs.gov
 Leonid Livshitz
  FDA/OC/CDRH/OPEQ/OHT1/DHT1A
  301-796-6975
  Leonid.Livshitz@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Groups (STG)
Radiology (primary)
Ophthalmic
*These are provided as examples and others may be applicable.
-
-