Radiology · 510(k) · 2018
Workflow Box
Mirada Medical Ltd.. Cleared by FDA on 10 July 2018 under submission K181572, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K181572
- Device. Workflow BoxDEVICE
- Company. Mirada Medical Ltd. (GB)COMPANY
- Decision. 10 July 2018, 510(k), substantially equivalent (traditional review); received 14 June 2018DECISION
- 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.
Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components. Supported modalities include CT, MR, RTSTRUCT Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring, re-contouring of the same patient and machine learning based contouring. Workflow Box is a data routing and image processing tool which automatically applies contours to data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning. Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications. Workflow Box is intended to be used by trained medical professionals. Workflow Box is not intended to automatically detect lesions.
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
- Mentionsdetection or identification of findings
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 2018. The whole record is at FDA AI-enabled medical devices.
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