NeuroLogica Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 8
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0480-2026 | Class II | GM85 Digital Mobile X-ray imaging System; Model Number: GM85; | October 7, 2025 |
| Z-2715-2024 | Class II | GM60A. Digital Diagnostic Mobile X-Ray System. | July 8, 2024 |
| Z-1056-2024 | Class II | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | December 28, 2023 |
| Z-2068-2023 | Class II | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the | June 6, 2023 |
| Z-1414-2023 | Class II | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System | March 8, 2023 |
| Z-2772-2020 | Class II | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version bef | July 15, 2020 |
| 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, 3.01.01, 3.0 | July 25, 2019 |
| 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, 2.01.05, 2.0 | July 25, 2019 |
| Z-1691-2019 | Class II | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging | May 6, 2019 |
| Z-1391-2018 | Class II | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digit | January 12, 2018 |
| Z-0726-2018 | Class II | The GC80 Digital X-ray Imaging System | June 22, 2017 |
| Z-3036-2017 | Class II | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic | May 24, 2017 |
| Z-0263-2016 | Class II | Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. | September 14, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250928 | OmniTom Elite with PCD | September 8, 2025 |
| K233767 | OmniTom Elite | June 10, 2024 |
| K213649 | BodyTom 64 | April 29, 2022 |
| K171183 | OmniTom | August 18, 2017 |
| K142697 | NExCT 7 | December 23, 2014 |
| K102677 | BODYTOM NL 4000 | March 24, 2011 |
| K090811 | INSPIRA HD, MODEL: NL1000 | August 27, 2009 |
| K051765 | CERETOM, MODEL NL3000 | July 14, 2005 |