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Image Management Software For Planning Of Otologic And Neurotologic Procedures

Page Type
Product Code
Definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
Physical State
software
Technical Method
Anatomical reconstruction of the target area and geometric measurements of relevant anatomy
Target Area
temporal bone, outer ear, middle ear, inner ear, facial nerve
Regulation Medical Specialty
Radiology
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2050
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.2050 Medical image management and processing system

§ 892.2050 Medical image management and processing system.

(a) 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.

(b) 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).

[63 FR 23387, Apr. 29, 1998, as amended at 86 FR 20284, Apr. 19, 2021]

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Page Type
Product Code
Definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
Physical State
software
Technical Method
Anatomical reconstruction of the target area and geometric measurements of relevant anatomy
Target Area
temporal bone, outer ear, middle ear, inner ear, facial nerve
Regulation Medical Specialty
Radiology
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2050
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.2050 Medical image management and processing system

§ 892.2050 Medical image management and processing system.

(a) 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.

(b) 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).

[63 FR 23387, Apr. 29, 1998, as amended at 86 FR 20284, Apr. 19, 2021]