| IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 12-292 |
| Extent | Complete standard |
| Standards Orgs | IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/ |
| STG | Radiology |
| FDA Tech | Shing Chun Benny Lam FDA/OMPT/CDRH/OCD/ 301-796-9328 shingchunbenny.lam@fda.hhs.gov |
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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).
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1750 | System, X-Ray, Tomography, Computed | Class 2 | JAK |
| §892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | IYO |
| §892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | IYN |
| §892.1200 | System, Tomography, Computed, Emission | Class 2 | KPS |
| §892.1000 | System, Nuclear Magnetic Resonance Imaging | Class 2 | LNH |
| §876.1500 | Endoscope, Accessories, Narrow Band Spectrum | Class 2 | NWB |
| §876.1500 | System, Surgical, Computer Controlled Instrument | Class 2 | NAY |
| Unclassified | Analyzer, Medical Image | Class 3 | MYN |
| Unclassified | Automated Breast Ultrasound | Class 3 | PAA |
| Unclassified | Digital Breast Tomosynthesis | Class 3 | OTE |
| There is no relevant guidance developed at this time. |