Radiology · 510(k) · 2020
Contour ProtegeAI
MIM Software Inc.. Cleared by FDA on 2 July 2020 under submission K193252, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K193252
- Device. Contour ProtegeAIDEVICE
- Company. MIM Software Inc.COMPANY
- Decision. 2 July 2020, 510(k), substantially equivalent (traditional review); received 25 November 2019DECISION
- Panel. RadiologyPANEL
- Product code. QKB, Radiological Image Processing Software For Radiation TherapyCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Contour ProtégéAI is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAI assists in the following indications: The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Contour ProtégéAI must be used in conjunction with MIM software to review and, if necessary, edit contours that were automatically generated by Contour ProtégéAI.
The product code's definition, from FDA's classification record. To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QKB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QKB, in Radiology, from MIM Software Inc., or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.