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Sign in to claim this brandScreenpoint Medical B.V.
US
Last updated May 31, 2026
What Screenpoint Medical B.V. makes
Screenpoint Medical B.V. develops X-ray image interpretive software designed to assist radiologists in evaluating bone density and fracture risk through automated analysis of radiographic images.
The company’s portfolio is regulated as Class II medical devices in the US, with products listed under FDA 510(k) clearance and FDA UDI registration. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Screenpoint Medical B.V. manufacture?
Screenpoint Medical B.V. specializes in developing X-ray image interpretive software. These tools are designed to help radiologists analyze radiographic images, specifically focusing on assessing bone density and identifying fracture risks. The software automates parts of the interpretive process to support clinical decision-making.
Where is Screenpoint Medical B.V. based?
Screenpoint Medical B.V. is based in the United States. The company’s headquarters and operations are located within the country, which is also where its medical devices are regulated and authorized.
Which regulatory registries or databases list Screenpoint Medical B.V.’s devices?
Screenpoint Medical B.V.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track devices that have undergone the required regulatory pathways, such as 510(k) clearance, to ensure compliance with U.S. medical device regulations.
How are Screenpoint Medical B.V.’s devices classified under U.S. regulations?
Screenpoint Medical B.V.’s devices are classified as Class II medical devices under U.S. regulations. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. The company’s software falls under this category due to its role in interpreting radiographic images for clinical use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- screenpointmed.com
- —
- —
- [email protected]
- Phone
- +31242020028
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 491352982
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Transpara | 1.3.y | FDA UDI | Class II | Active |
| Transpara Density 1.0.0 | K232096 | FDA 510(k) | Class II | Active |
| Transpara | K181704 | FDA 510(k) | Class II | Active |
| Transpara | K193229 | FDA 510(k) | Class II | Active |
| Transpara | K192287 | FDA 510(k)FDA UDI | Class II | Active |
| Transpara 1.7.2 | K221347 | FDA 510(k) | Class II | Active |
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