Radiology · 510(k) · 2022
AutoContour Model RADAC V2
Radformation, Inc.. Cleared by FDA on 24 August 2022 under submission K220598, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K220598
- Device. AutoContour Model RADAC V2DEVICE
- Company. Radformation, Inc.COMPANY
- Decision. 24 August 2022, 510(k), substantially equivalent (traditional review); received 2 March 2022DECISION
- 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 (17 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.
AutoContour is intended to assist radiation treatment planners in contouring andreviewing structures within medical images in preparation for radiation therapy treatmentplanning. 5.6. Technological CharacteristicsSubject Device, AutoContour RADAC V2 makes use of a Predicate Device, AutoContourRADAC (K200323) as the Predicate Device for substantial equivalence comparison.The functionality and technical components of this prior submission remain unchanged inAutoContour RADAC V2. This submission is intended to build on the functionality andtechnological components of the 510(k) cleared AutoContour RADAC. 5.6.1.Updates vs. AutoContour (K200323)The updated submissions expanded the machine-learning based contouring andmanual ROI manipulation to Magnetic Resonance (MR) image types as well asexpanded the number of supported CT structure models. Additionally, image registrationis expanded to include deformable image registration for the purposes of transferringstructure contours from one image set to another. K220598 Table 3: Technological CharacteristicsAutoContour RADAC V2 vs. AutoContour RADAC (K200323) Characteristic Subject Device: AutoContourRADAC V2
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
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 Radformation, Inc., or cleared in 2022. The whole record is at FDA AI-enabled medical devices.
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