What the FDA Record Shows About the ScreenPoint Medical Transpara 2.1.0 Clearance

The FDA premarket notification record for K260898 names the device as Transpara (2.1.0), the applicant as Screenpoint Medical B.V., and the decision date as 14 August 2026, with a decision description of substantially equivalent. The record lists the product code as QDQ, the regulation name as radiology, and the type of submission as Special. A Special 510(k) is the route used for a modification to a device the applicant has already had cleared. The record states a clearance and does not state any finding about clinical performance. This is the seventh Transpara clearance in this site's own device records for that applicant, which also list K241831 from November 2024, K221347, K210404, K193229, K192287 and K181704 going back to 2018.

Why the ScreenPoint Medical Transpara 2.1.0 Clearance Matters to Breast Imaging Buyers

Clearance is a market permission, not a performance grade. The FDA found this version substantially equivalent to a device already on the market, which is a comparison to a predecessor rather than a judgement that the software helps radiologists. The reason to care is version control. ScreenPoint now has seven clearances across eight years for the same product family, and the published trial evidence people quote was generated on a particular version. Before signing anything, a buyer should make the contract name the cleared version being installed, because a product name alone no longer identifies what was tested or what was cleared.

Where the ScreenPoint Medical Update Comes From

FDA 510(k) premarket notification database is the original record behind this update. It tells us what the company published. This brief adds the market context and the method we would use to test the development against other evidence.

FDA 510(k) premarket notification database original source.

How We Would Research the ScreenPoint Medical Transpara 2.1.0 Clearance

The source gives us the starting point. This is how we would build the next layer of research around it.

  1. We would pull the 510(k) summary document for K260898 from the FDA record to see what changed from the predicate device, since a Special 510(k) is filed for a modification.
  2. Then we would ask ScreenPoint which cleared version a quoted study used, because the published screening evidence and the version on sale are not automatically the same software.
  3. We would check the product code QDQ listing to see which competitors sit under the same classification, which is the quickest way to build a comparison set that regulators already treat as equivalent.