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Recognized Consensus Standards
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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
Standard
IEEE Std 3333.2.1-2015
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
Scope/Abstract
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
Unclassified Automated Breast Ultrasound Class 3 PAA
Unclassified Digital Breast Tomosynthesis Class 3 OTE
§892.2070 Analyzer, Medical Image Class 2 MYN
Regulation Number Device Name Device Class Product Code
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
Regulation Number Device Name Device Class Product Code
§892.1200 System, Tomography, Computed, Emission Class 2 KPS
Regulation Number Device Name Device Class Product Code
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
Regulation Number Device Name Device Class Product Code
§876.1500 Endoscope, Accessories, Narrow Band Spectrum Class 2 NWB
§876.1500 System, Surgical, Computer Controlled Instrument Class 2 NAY
Regulation Number Device Name Device Class Product Code
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
Regulation Number Device Name Device Class Product Code
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
FDA Technical Contact
 Shing Chun Benny Lam
  FDA/OMPT/CDRH/OCD/
  301-796-9328
  shingchunbenny.lam@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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