Trade Resources Industry Views Sectra Registered Sectra Dosetrack with The US FDA

Sectra Registered Sectra Dosetrack with The US FDA

Sectra has registered Sectra DoseTrack, a new class 1 software medical device, with the US Food and Drug Administration (FDA).

Sectra DoseTrack is a web-based solution to monitor patient radiation doses and check whether they are kept as low as possible.

Automatically the system can collect, store and monitor the entire data from all the connected modalities, which in turn saves time and helps analysis. This allows in the easy tracking and comparison of radiation levels on modality, examination or patient level.

The device supports the IHE radiation exposure monitoring profile, DICOM MPPS, DICOM Radiation Dose Structured Report, Optical Character Recognition, and manual input.

The company claimed that this enables the connection of modality to gain a full enterprise-wide dose monitoring solution.

For almost five years, Region Skne in Sweden has been using Sectra DoseTrack as a regional quality system to collate, store and analyze radiation dose monitoring data from more than two million radiology examinations performed at about 100 radiology modalities.

 

Source: http://healthcareit.medicaldevices-business-review.com/news/sectra-registers-radiation-dose-monitoring-solution-with-us-fda-090713
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Sectra Registers Radiation Dose Monitoring Solution with US FDA