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510(k) Clearance Granted for OncoTrac


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FDAlogoTranslational Sciences Corporation announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac medical imaging software. OncoTrac is designed for efficient quantitative assessment of treatment response of metastatic tumors including those of the breast, lung, colorectal, prostate, and lymphoma. The OncoTrac family of products provides a structured workflow solution for cancer practitioners and researchers to report precise measurements of solid and metastatic tumors for routine clinical care and cancer drug trials.

As a vendor-neutral platform, OncoTrac software architecture is suitable for use in daily radiology practice, and can be integrated into most existing picture and archive communications systems (PACS) environments without any product customization. OncoTrac enterprise software facilitates tumor response assessment using widely accepted standards such as RECIST 1.0, RECIST 1.1, and WHO, as well as emerging standards such as the Choi criteria. Reports can be exported and stored in both a PACS system and in an electronic medical record. ■


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