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/AbstractThis 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
|
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
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |
|
|