NeuroLogica Corporation
Medical device manufacturer in Danvers, MA.
8510(k) clearances
0PMA approvals
13recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250928 | OmniTom Elite with PCDJAK · Traditional | 09/08/2025SE |
| K233767 | OmniTom EliteJAK · Traditional | 06/10/2024SE |
| K213649 | BodyTom 64JAK · Traditional | 04/29/2022SE |
| K171183 | OmniTomJAK · Traditional | 08/18/2017SE |
| K142697 | NExCT 7JAK · Traditional | 12/23/2014SE |
| K102677 | Bodytom NL 4000JAK · Traditional | 03/24/2011SE |
| K090811 | Inspira HD, Model: NL1000KPS · Abbreviated | 08/27/2009SE |
| K051765 | Ceretom, Model NL3000JAK · Traditional | 07/14/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0480-2026 Class II | 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… | 10/07/2025Open, Classified |
| Z-2715-2024 Class II | GM60A. Digital Diagnostic Mobile X-Ray System.Potential for the anti-fall system of the device arm to fail. | 07/08/2024Open, Classified |
| Z-1056-2024 Class II | 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… | 12/28/2023Open, Classified |
| Z-2068-2023 Class II | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be…1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the… | 06/06/2023Open, Classified |
| Z-1414-2023 Class II | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray SystemIssue related to the operation of the arm latch within the column that supports the arm, potential bodily… | 03/08/2023Open, Classified |
| Z-2772-2020 Class II | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software…There are potential issues related to the operational state of the scanner, specifically for transport and… | 07/15/2020Terminated |
| Z-2276-2019 Class II | WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00…There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by… | 07/25/2019Terminated |
| Z-2275-2019 Class II | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04…There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by… | 07/25/2019Terminated |
| Z-1691-2019 Class II | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray…Potential issue related to the operation of the safety latch within the column that supports the arm due to… | 05/06/2019Terminated |
| Z-1391-2018 Class II | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat…While transporting the portable machine with the retrofit equipment in a backwards motion, there is… | 01/12/2018Terminated |
| Z-0726-2018 Class II | The GC80 Digital X-ray Imaging SystemAn image was obtained with over exposure during a Thorax examination using the AEC function. | 06/22/2017Terminated |
| Z-3036-2017 Class II | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating…When performing the Stitching function on GU60A system, unintended area is exposed to radiation | 05/24/2017Terminated |
| Z-0263-2016 Class II | 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… | 09/14/2015Terminated |