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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 12-292
IEEE  Std 3333.2.1-2015
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
This standard includes volume- and surface-rendering techniques for 3D reconstruction from 2D medical images. Also, it contains a texturing method of 3D medical data for realistic visualization. Standardization related to medical services includes medical equipment utilizing 2D images, 3D medical data, and contents for diagnosis and treatment. Standardization of medial contents, software, and hardware will enhance safety, economy, and quality of 3D medical services. (see Figure 2).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.1500 System, Surgical, Computer Controlled Instrument Class 2 NAY
§876.1500 Endoscope, Accessories, Narrow Band Spectrum Class 2 NWB
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1200 System, Tomography, Computed, Emission Class 2 KPS
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
§892.2070 Analyzer, Medical Image Class 2 MYN
N/A Digital Breast Tomosynthesis Class 3 OTE
N/A Automated Breast Ultrasound Class 3 PAA
Relevant FDA Guidance and/or Supportive Publications*
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 Contact
 Shing Chun Benny Lam
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.