Siemens Medical Solutions
Danvers, MA, US
Siemens Medical Solutions appears in FDA device records in Danvers, MA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Siemens Medical Solutions between 2003 and 2025. The busiest year on record is 2006, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250738 | YSIO X.pree | KPR | Substantially Equivalent | |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | OWB | Substantially Equivalent | |
| K233543 | YSIO X.pree | KPR | Substantially Equivalent | |
| K233532 | MULTIX Impact E | KPR | Substantially Equivalent | |
| K231577 | MOBILETT Impact | IZL | Substantially Equivalent | |
| K221281 | Multitom Rax | OWB | Substantially Equivalent | |
| K212212 | Multitom Rax with True2scale Body Scan Option | OWB | Substantially Equivalent | |
| K101749 | SYNGO TRUED SOFTWARE | LLZ | Substantially Equivalent | |
| K081018 | SYNGO DYNAMICS VERSION 7.0 | LLZ | Substantially Equivalent | |
| K071513 | INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | JAK | Substantially Equivalent | |
| K070629 | FLEX AND LOOP COIL SET 1.5 T | MOS | Substantially Equivalent | |
| K061671 | SYNGO TRUED, MODEL VC10A | LLZ | Substantially Equivalent | |
| K060992 | SYNGO US WORKPLACE | LLZ | Substantially Equivalent | |
| K043030 | MAGNETOM C! MR SYSTEM | LNH | Substantially Equivalent | |
| K030657 | SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 | MHX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MOSCoil, Magnetic Resonance, Specialty
- OWBInterventional Fluoroscopic X-Ray System
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain