The evidence behind the score, not just the score.
TI-RADS itself is a published, peer-reviewed standard, and that’s covered on the Clinical Approach & TI-RADS page. This page is everything else: the published research our clinical and research team has put out, the certifications actually on file, and exactly where we stand on formal regulatory clearance.
Six papers, six angles on the same problem. Published by Traick’s clinical and research team, before and alongside the product: thyroid imaging, nodule segmentation and classification.
- 2017·Clinical StudyImaging & diagnosis
“Evaluation of Parenchymal Thyroid Diseases with Multiparametric Ultrasonography”
Diffuse thyroid parenchymal disease assessed with a multiparametric ultrasound approach.
Yıldırım D, Alis D, Bakır A, Ustabaşıoğlu FE, Samancı C, Çolakoğlu B.
Indian Journal of Radiology and Imaging, 27(4):463–469 · PMID 29379243
- 2016·Clinical StudyImaging & diagnosis
“Elastography in Distinguishing Benign from Malignant Thyroid Nodules”
An elastography-based approach to distinguishing benign from suspicious thyroid nodules.
Çolakoğlu B, Yıldırım D, Alış D, Uçar G, Samancı C, Ustabaşıoğlu FE, Bakır A, Ulusoy OL.
Journal of Clinical Imaging Science, Vol. 6 · DOI: 10.4103/2156-7514.197074
- 2024·Technical PaperAI & segmentation
“Segmentation of Thyroid Nodules on Ultrasound Images”
Segmentation methodology published in the Journal of Naval Sciences and Engineering.
Bektaş Güneş B, Samlı R, Doğan MB, Yıldırım D.
Vol. 20(2):191–211 · DOI: 10.56850/jnse.1507140
- 2024·Technical PaperAI & segmentation
“Multi-Class Classification of Thyroid Nodules from Automatic Segmented Ultrasound Images: Hybrid ResNet Based UNet Convolutional Neural Network Approach”
Published in Computer Methods and Programs in Biomedicine (Elsevier).
Gökmen İnan N, Kocadağlı O, Yıldırım D, Meşe İ, Kovan Ö.
Vol. 243, article 107921 · DOI: 10.1016/j.cmpb.2023.107921
- 2019·Reference BookReference & other clinical
“Tiroid Kanseri (Thyroid Cancer)”
Book chapter contribution, edited by Prof. Dr. Mete Düren.
ISBN 9786058114331
- 2020·Clinical StudyReference & other clinical
“Ultrasound findings in Hashimoto’s thyroiditis”
Published in the International Journal of Clinical Medicine.
ISSN 2158-2882 / 2158-284X
Real certificates, held by the right legal name. Datasurgery Yazılım ve Danışmanlık Anonim Şirketi holds the four certifications below. Traick is a product built by Datasurgery.
ISO 9001:2015
Quality management systems
Held by Datasurgery A.Ş.
ISO/IEC 27001:2022
Information security management (also holds TS ISO/IEC 27001:2022)
Held by Datasurgery A.Ş.
ISO 13485:2016
Medical devices, quality management systems
Held by Datasurgery A.Ş.
EN ISO/IEC 27701:2021
Privacy information management
Held by Datasurgery A.Ş.
A roadmap, not a certification. Traick does not currently hold FDA clearance or a CE-MDR mark. This is the four-part cycle we’re working through, and what each part actually means.
Not complete
None of the four is finished yet
FDA SaMD roadmap
Mapping Traick against the FDA’s Software as a Medical Device framework and identifying which regulatory pathway applies to a scoring-support tool like ours.
These four parts inform each other rather than running strictly in sequence, and none of them is complete yet. Until this page says otherwise, Traick is a clinical decision-support tool, not a certified diagnostic device.