Data / Medical devices / United States / Samsung HME America, Inc.
Samsung HME America, Inc.: FDA-registered device maker in Danvers, MA, United States, 7 510(k) clearances
Samsung HME America, Inc. is registered with the FDA (registration 3004938766) in Danvers, MA, United States. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated September 8, 2025. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004938766
- Address
- 14 Electronics Ave, Danvers, MA, United States, 01923
- Owner or operator
- Samsung Electronics Co., Ltd. (10043488)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 22, 2017
- Registered through
- 2026
- Brand names listed
- BodyTom 64, BodyTom Elite, CereTom Elite, OmniTom Elite, OmniTom Elite with PCD, VetTom 32, VetTom 8
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 8, 2025 | K250928 | OmniTom Elite with PCD | JAK | Substantially Equivalent | Neurologica Corporation | accessdata.fda.gov |
| March 14, 2025 | K242811 | BodyTom 64 | JAK | Substantially Equivalent | Neurologica Corporation, A Subsidiary of Samsung | accessdata.fda.gov |
| June 10, 2024 | K233767 | OmniTom Elite | JAK | Substantially Equivalent | Neurologica Corporation | accessdata.fda.gov |
| June 1, 2023 | K223447 | OmniTom Elite | JAK | Substantially Equivalent | Neurologica Corporation, A Subsidiary of Samsung | accessdata.fda.gov |
| February 25, 2022 | K211711 | OmniTom Elite | JAK | Substantially Equivalent | Neurologica Corporation, A Subsidiary of Samsung Electronics | accessdata.fda.gov |
| November 22, 2017 | K172539 | CereTom Elite | JAK | Substantially Equivalent | Neurologica Corporation, A Subsidiary of Samsung Electronics | accessdata.fda.gov |
| June 14, 2017 | K170238 | BodyTom Elite | JAK | Substantially Equivalent | Neurologica Corporation, A Subsidiary of Samsung Electronics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 7, 2025 | 97721 | Class II | Ongoing | GM85 Digital Mobile X-ray imaging System; Model Number: GM85 | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. | accessdata.fda.gov |
| July 8, 2024 | 95100 | Class II | Ongoing | GM60A. Digital Diagnostic Mobile X-Ray System. | Potential for the anti-fall system of the device arm to fail. | accessdata.fda.gov |
| December 28, 2023 | 93803 | Class II | Ongoing | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. | accessdata.fda.gov |
| June 6, 2023 | 92506 | Class II | Ongoing | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000 | 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment | accessdata.fda.gov |
| March 8, 2023 | 91959 | Class II | Ongoing | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System | Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm | accessdata.fda.gov |
| July 15, 2020 | 86052 | Class II | Terminated | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be | There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed. | accessdata.fda.gov |
| July 25, 2019 | 83429 | Class II | Terminated | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12 | There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode. | accessdata.fda.gov |
| May 6, 2019 | 82862 | Class II | Terminated | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. Th | Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks. | accessdata.fda.gov |
| January 12, 2018 | 79628 | Class II | Terminated | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical | While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit. | accessdata.fda.gov |
| June 22, 2017 | 78679 | Class II | Terminated | The GC80 Digital X-ray Imaging System | An image was obtained with over exposure during a Thorax examination using the AEC function. | accessdata.fda.gov |
| May 24, 2017 | 77384 | Class II | Terminated | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applic | When performing the Stitching function on GU60A system, unintended area is exposed to radiation | accessdata.fda.gov |
| September 14, 2015 | 72171 | Class II | Terminated | Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. | When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted. | accessdata.fda.gov |
Compare with other makers
Updated November 7, 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.