Screenpoint Medical
Nijmegen Gelderland, NL
SCREENPOINT MEDICAL appears in FDA device records in Nijmegen Gelderland, NL. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Screenpoint Medical between 2018 and 2026. The busiest year on record is 2018, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260898 | Transpara (2.1.0) | QDQ | Substantially Equivalent | |
| K241831 | Transpara (2.1.0) | QDQ | Substantially Equivalent | |
| K232096 | Transpara Density 1.0.0 | QIH | Substantially Equivalent | |
| K221347 | Transpara 1.7.2 | QDQ | Substantially Equivalent | |
| K210404 | Transpara 1.7.0 | QDQ | Substantially Equivalent | |
| K193229 | Transpara | QDQ | Substantially Equivalent | |
| K192287 | Transpara | QDQ | Substantially Equivalent | |
| K181704 | Transpara | QDQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015173173 | 3015173173 | SCREENPOINT MEDICAL | Mercator II, 7th floor, Nijmegen Gelderland 6525 EC NL | 2026 | |
| 3030412475 | 3030412475 | ScreenPoint Medical, Inc. | 8 The Green, Suite B, Dover, DE 19901 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain