| 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/AbstractDigital 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
|
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| FDA recognition of NEMA PS 3.1 - 3.20 2022d [Rec# 12-349] will be superseded by recognition of NEMA PS 3.1 - 3.20 2023e [Rec# 12-352].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
|
| Standards Development Organization
|
FDA Specialty Task Groups (STG)
| Radiology (primary) |
| Ophthalmic |
|
| *These are provided as examples and others may be applicable. |
