21 CFR 892.2050 — System, Image Processing, Radiological
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.2050
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | 2263 | 3rd Party |
| NWE | Colon Computed Tomography System, Computer Aided Detection | 2 | 4 | SaMD |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 19 | SaMD |
| OMJ | Chest X-Ray Computer Aided Detection | 2 | 1 | SaMD |
| PGY | Display, Diagnostic Radiology | 2 | 134 | SaMD, 3rd Party |
| QIH | Automated Radiological Image Processing Software | 2 | 282 | AI/ML, SaMD |
| QKB | Radiological Image Processing Software For Radiation Therapy | 2 | 46 | AI/ML, SaMD |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 2 | 7 | SaMD |
Special Controls
LLZ — System, Image Processing, Radiological
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
NFJ — System, Image Management, Ophthalmic
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
NWE — Colon Computed Tomography System, Computer Aided Detection
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
OEB — Lung Computed Tomography System, Computer-Aided Detection
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
OMJ — Chest X-Ray Computer Aided Detection
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
PGY — Display, Diagnostic Radiology
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
PZO — Software For Visualization Of Vascular Anatomy And Intravascular Devices
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
QIH — Automated Radiological Image Processing Software
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
QKB — Radiological Image Processing Software For Radiation Therapy
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
QQE — Image Management Software For Planning Of Otologic And Neurotologic Procedures
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
QTZ — Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
eCFR
