Data / Medical devices / United States / Siemens Medical Solutions Usa, Inc.
Siemens Medical Solutions Usa, Inc.: FDA-registered device maker in Knoxville, TN, United States, 17 510(k) clearances
Siemens Medical Solutions Usa, Inc. is registered with the FDA (registration 1034973) in Knoxville, TN, United States. It lists 3 device types. The FDA files 17 510(k) clearances under its listings, the newest dated July 31, 2025. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1034973
- Address
- 810 Innovation DR., Knoxville, TN, United States, 37932
- Owner or operator
- SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 7, 2005
- Registered through
- 2026
- Brand names listed
- ASM CS-10-14 Calibration Source, ASM Line SRC LS-30 HRRT, ASM Line Source MR-PET, ASM SRC LS-Exact Line SRCS, BIograph mCT S, Biograph 16 TP-3R, Biograph 16 TP-4R, Biograph 16 TruePoint and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source, Calibration, Sealed, Nuclear | IXD | 1 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 31, 2025 | K251561 | Biograph Trinion | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 3, 2025 | K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 12, 2024 | K233677 | Biograph VK10 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 13, 2023 | K231833 | Biograph Vision.X and Biograph Vision.X Edge | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 22, 2022 | K223547 | Biograph Vision Quadra PET/CT System | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 3, 2021 | K210262 | Biograph Vision Quadra PET/CT System | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 14, 2020 | K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 12, 2020 | K193178 | Biograph Horizon | KPS | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| May 6, 2019 | K190900 | Biograph Vision | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 23, 2018 | K180811 | Biograph Vision | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173578 | Biograph mCT Family of PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 1, 2017 | K170904 | Biograph Horizon PET/CT | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 12, 2016 | K152880 | Biograph Horizon PET/CT | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 17, 2015 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 12, 2014 | K141971 | BIOGRAPH TRUE PET/CT FAMILY SOFTWARE | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 17, 2011 | K113448 | BIOGRAPH MCT FAMILY | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101550 | BIOGRAPH MCT FAMILY | KPS | 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 |
|---|---|---|---|---|---|---|
| February 20, 2017 | 76228 | Class II | Terminated | Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitti | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | accessdata.fda.gov |
| December 13, 2016 | 76127 | Class II | Terminated | Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | accessdata.fda.gov |
| April 25, 2016 | 74239 | Class II | Terminated | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. | accessdata.fda.gov |
| April 22, 2016 | 74192 | Class II | Terminated | Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | accessdata.fda.gov |
| July 14, 2015 | 71712 | Class II | Terminated | Biograph mCT S(40)-4R, Model Number 10248671 | Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. | accessdata.fda.gov |
| November 13, 2014 | 69897 | Class II | Terminated | Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusio | Possibility for system display freeze during CT interventional procedures. | accessdata.fda.gov |
| August 11, 2009 | 53453 | Not yet classified | Terminated | Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment. | In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly. | accessdata.fda.gov |
| July 23, 2007 | 45154 | Not yet classified | Terminated | Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA | Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions. | accessdata.fda.gov |
| July 23, 2007 | 45153 | Not yet classified | Terminated | Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA | Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) | accessdata.fda.gov |
| March 28, 2006 | 35001 | Not yet classified | Terminated | ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems o | There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan. | accessdata.fda.gov |
| April 5, 2005 | 31770 | Not yet classified | Terminated | ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile | Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit. | accessdata.fda.gov |
| May 27, 2004 | 30802 | Not yet classified | Terminated | PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT | Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set. | accessdata.fda.gov |
| October 2, 2003 | 27358 | Not yet classified | Terminated | Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT | CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion. | accessdata.fda.gov |
| March 4, 2003 | 25710 | Not yet classified | Terminated | ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL C | Incorrect patient information is displayed in the reconstructed images of a whole body patient scan. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Tomography, Computed, Emission
- All makers of Source, Calibration, Sealed, Nuclear
Updated July 31, 2025. 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.