Seg Pro V3 (RT-300)

Retrieved 2026-10-29 · 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.

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. Please provide the device trade name(s). I K251306 Seg Pro V3 (RT-300) [Please provide your Indications for Use below. Seg Pro V3 is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk on DICOM images. Seg Pro V3 is intended to be used on adult patients only. The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. Seg Pro V3 must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. Seg Pro V3 is not intended to be used for decision making or to detect lesions. 1 Seg Pro V3 is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring o the normal organs on DICOM images. Clinicians must not use the software generated output alone without review as the primary interpretation. Please select the types of uses (select one or both, as applicable).I Z Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C) Seg Pro V3 510(k) Summary

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.

• Mentionsan adjunct to the clinician, not a replacement
• Mentionsdetection or identification of findings
• Mentionsprescription use
• Mentionsadult patients

Adverse-event reports in MAUDE, by product code

As of 2026-10-29, 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

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