| 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
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §892.1560 |
System, Imaging, Pulsed Echo, Ultrasonic |
Class 2 |
IYO |
| §892.1750 |
System, X-Ray, Tomography, Computed |
Class 2 |
JAK |
|
| Unclassified |
Automated Breast Ultrasound |
Class 3 |
PAA |
| Unclassified |
Digital Breast Tomosynthesis |
Class 3 |
OTE |
| §892.2070 |
Analyzer, Medical Image |
Class 2 |
MYN |
| §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 |
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
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