Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Healthcare GmbH · Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
240 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | 2026-06-16 | 260 | 0 |
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2026-04-10 | 240 | 0 |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | 2026-04-10 | 140 | 0 |
| K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 2026-01-22 | 122 | 0 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM V | Siemens Healthcare GmbH | 2025-12-19 | 105 | 0 |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | 2025-09-09 | 22 | 0 |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; | Siemens Healthcare GmbH | 2025-06-16 | 122 | 2 |
| K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | 2025-04-03 | 219 | 0 |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2025-03-27 | 197 | 0 |
| K241770 | Prostate MR AI (VA10A) | Siemens Healthcare GmbH | 2025-03-05 | 258 | 0 |
| K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | 2024-08-06 | 137 | 0 |
| K240294 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH | 2024-05-23 | 112 | 0 |
| K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2024-03-21 | 120 | 0 |
| K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023-12-21 | 105 | 0 |
| K232856 | Syngo Carbon Clinicals | Siemens Healthcare GmbH | 2023-12-01 | 77 | 0 |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023-07-19 | 86 | 0 |
| K230561 | Syngo Carbon Space VA30A | Siemens Healthcare GmbH | 2023-03-21 | 21 | 0 |
| K230196 | syngo.via View&GO VA40A | Siemens Healthcare GmbH | 2023-02-13 | 19 | 0 |
| K221501 | syngo.via View&GO | Siemens Healthcare GmbH | 2022-10-14 | 144 | 0 |
| K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2022-08-11 | 260 | 0 |
| K213665 | Syngo Carbon Space VA20A | Siemens Healthcare GmbH | 2022-06-21 | 211 | 0 |
| K213706 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 2022-04-15 | 142 | 0 |
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021-03-31 | 146 | 0 |
| K201477 | syngo.via View&GO | Siemens Healthcare GmbH | 2020-07-01 | 28 | 0 |
| K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | 2019-05-16 | 27 | 0 |
| K182208 | syngo.via View&GO (Version VA10A) | Siemens Healthcare GmbH | 2018-09-07 | 23 | 0 |
| K180563 | syngo.plaza | Siemens Healthcare GmbH | 2018-04-25 | 51 | 0 |
| K173378 | syngo®.via protoNeo (Version VA20) | Siemens Healthcare GmbH | 2017-11-20 | 21 | 0 |
| K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | 2017-06-01 | 52 | 0 |
| K170221 | syngo.CT Cardiac Planning | Siemens Healthcare GmbH | 2017-04-21 | 86 | 0 |
| K161685 | syngo®.via protoNeo (Version VA10A) | Siemens Healthcare GmbH | 2016-07-11 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda