Class Class II
Biograph Trinion (K251561)
Description
Biograph Trinion by Siemens Medical Solutions USA, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251561
Clearance Date2025-07-31
Clearance TypeSpecial
Product CodeKPS
Regulation Number892.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251561
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Biograph Trinion (K251561) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242300 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2024 |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.T... | Siemens Medical Solutions USA, Inc. | 2024 |
| K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | 2024 |
| K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | 2023 |
Trace the full predicate network for K251561
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.