Data / Medical devices / United States / Siemens Medical Solutions Usa, Inc.
Siemens Medical Solutions Usa, Inc.: FDA-registered device maker in Ann Arbor, MI, United States, 6 510(k) clearances
Siemens Medical Solutions Usa, Inc. is registered with the FDA (registration 1836549) in Ann Arbor, MI, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 10, 2026. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1836549
- FEI number
- 3003304172
- Address
- 400 W. Morgan Road, Ann Arbor, MI, United States, 48108
- Owner or operator
- SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
- Roles
- Manufacturer
- First device listed
- July 31, 2020
- Registered through
- 2026
- Brand names listed
- Syngo Dynamics, Syngo Dynamics VA30, syngo Dynamics, syngo Dynamics VA40E, syngo Dynamics VA40F, syngo Dynamics VA41D, syngo Dynamics VA41F
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K253689 | syngo Dynamics (VA41F) | QIH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| April 3, 2025 | K242551 | syngo Dynamics (Version VA41D) | QIH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| November 14, 2022 | K222428 | Syngo Dynamics (Version VA40F) | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 20, 2022 | K220832 | syngo Dynamics (Version VA40E) | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 1, 2017 | K171053 | syngo Dynamics Version VA30 | LLZ | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| January 16, 2013 | K123922 | SYNGO DYNAMICS | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 13, 2012 | 62581 | Class II | Terminated | syngo Dynamics Version 9.5 | If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study. | accessdata.fda.gov |
| May 10, 2011 | 58830 | Not yet classified | Terminated | syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images | For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report. | accessdata.fda.gov |
| March 24, 2011 | 58545 | Not yet classified | Terminated | syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and mani | If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed. | accessdata.fda.gov |
| July 23, 2008 | 49457 | Not yet classified | Terminated | Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medi | If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report. | accessdata.fda.gov |
| February 8, 2008 | 46823 | Not yet classified | Terminated | Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system | Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file. | accessdata.fda.gov |
| January 31, 2007 | 37347 | Not yet classified | Terminated | Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system. | The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect. | accessdata.fda.gov |
| April 6, 2006 | 35043 | Not yet classified | Terminated | KinetDx 4.0 Ultrasound Image Management System. | The cardiologist's report comments may not be retained by the system due to a software bug. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.