Radiology · 510(k) · 2020
AccuContour
Xiamen Manteia Technology LTD.. Cleared by FDA on 28 February 2020 under submission K191928, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K191928
- Device. AccuContourDEVICE
- Company. Xiamen Manteia Technology LTD. (CN)COMPANY
- Decision. 28 February 2020, 510(k), substantially equivalent (traditional review); received 19 July 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 (9 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.
It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. 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 ACR/NEMA 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 evaluation, and treatment planning. • Evaluation of cardiac left ventricular function and perfusion, including left ventricular enddiastolic 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, transferring contours to radiation therapy treatment planning systems, and 5 / 6 ITEM Proposed Device Predicate Device K182624 archiving contours for patient follow-up and management. • Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other […]
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
- Mentionsa diagnostic claim
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, 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.