(85 days)
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT. MRI. CR. DX. MG. US. SPECT. PET and XA as supported by ACRNEMA DICOM 3.0. MIM assists in the following indications:
- · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
- · Create, display and print reports from medical images.
- · Registration, fusion display, and review of medical images for diagnosis, treatment planning,
· Evaluation of cardiac left ventricular function, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transfering contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). - · Post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The software is not to be used for mammography CAD.
MIM - SPECTRA Quant is a feature of MIM. It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - SPECTRA Quant extends the functionality MIM - Y90 Dosimetry (K172218) software. The following functions have been added to allow quantitative reconstructions of Single Photon Emission Computed Tomography (SPECT) scans:
- Allows for decay correction of activity back to time of injection ●
- Allows for correction of photon attenuation ●
- . Allows for correction of photon scatter
- Allows for correction of collimator detector resolution effects ●
- Allows for camera sensitivity calibration providing output in Becquerels per ml (Bq/ml) .
Here's a breakdown of the acceptance criteria and study details for MIM - SPECTRA Quant based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Isotope | Collimator | Acceptance Criteria (Quantitative Error) | Reported Quantitative Error | Verification Result |
|---|---|---|---|---|
| Tc99m | LEHR |
§ 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).