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Neurologica Corporation

Last updated May 23, 2026

What Neurologica Corporation makes

Neurologica Corporation manufactures medical positioning and imaging accessories, including head/neck procedure positioners like the OPTION ASSY OMNITOM Universal Transfer Board and CERETOM Frazer Base Plate and Rails System. Their portfolio also includes CT system components such as the CereTom Elite and workstation adapters for hospital beds, including the Stryker Bed Adapter and LINET Multicare Bed Adapter. Additionally, they produce diagnostic imaging tools like the Large Veterinary Platform and Extended Universal Scan Board, as well as x-ray phantoms and digital imaging scanners.

These devices are classified under FDA Class II regulations and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The company’s products are intended for use in radiology and emergency medical settings, supporting imaging and patient transfer procedures.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (74)

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Device	Model / Reference	Registries	Class	Status
Option, Hill-Rom Versacare Adapter W/ 5" Riser	0-00118-002	FDA UDI	Class II	Active
Transfer Board Assembly	0-00036-001	FDA UDI	Class II	Active
Option, Nl4x00 Ws-240v-S	0-00132-002	FDA UDI	Class II	Active
30cm Water Phantom	10-01148-001	FDA UDI	Class II	Active
Option, Stryker Primex Bed Adapter	0-00162-001	FDA UDI	Class II	Active
Option, Extended Scanboard Short Post With Target	0-00202-002	FDA UDI	Class II	Active
Hill Rom Bed Adapter	0-00142-001	FDA UDI	Class II	Active
Option, Hill-Rom Chg Bed Adapter	0-00174-001	FDA UDI	Class II	Active
Neo-Natal Scanning Platform	0-00072-001	FDA UDI	Class II	Active
Option, Ws Cart Nl4000	0-00132-001	FDA UDI	Class II	Active
Ct Scanner, Nl5000	0-NL5000-001	FDA UDI	Class II	Active
Large Veterinary Scanning Platform	0-00084-001	FDA UDI	Class II	Active
Neonatal Scanning Platform, Nl5000	0-00154-001	FDA UDI	Class II	Active
Assy, Scan Board, Hill-Rom Progressa	0-00139-001	FDA UDI	Class II	Active
Option, Extended Hill-Rom Progressa Pulmonary Scan Board	0-00150-002	FDA UDI	Class II	Active
Ct Scanner, Nl4000 Elite	0-NL4000-002	FDA UDI	Class II	Active
Bodytom Nl 4000	K102677	FDA 510(k)	Class II	Active
Inspira Hd, Model: Nl1000	K090811	FDA 510(k)	Class II	Active
Ceretom, Model Nl3000	K051765	FDA 510(k)	Class II	Active
NExCT 7	K142697	FDA 510(k)	Class II	Active
OmniTom	K171183	FDA 510(k)	Class II	Active
BodyTom 64	K213649	FDA 510(k)	Class II	Active
OmniTom Elite	K233767	FDA 510(k)	Class II	Active
OmniTom Elite with PCD	K250928	FDA 510(k)	Class II	Active

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FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Neurologica Corporation has initiated 13 recall records between September 14, 2015, and October 7, 2025, with statuses including open, classified, and terminated. The recalls involve various issues with medical imaging and mobility devices, including radiation exposure risks, mechanical failures (such as arm latches, column supports, and welding defects), battery malfunctions, overheating probes, loosened components, and potential transport hazards. Reasons cited include operational malfunctions, improper system behavior, and structural integrity concerns, some referencing unintended exposure or delays in treatment if instructions are not followed.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 7, 2025	Z-0480-2026	—	open, classified	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.
Jul 8, 2024	Z-2715-2024	—	open, classified	Potential for the anti-fall system of the device arm to fail.
Dec 28, 2023	Z-1056-2024	—	open, classified	Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Jun 6, 2023	Z-2068-2023	—	open, classified	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
Mar 8, 2023	Z-1414-2023	—	open, classified	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
Jul 15, 2020	Z-2772-2020	—	terminated	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.
Jul 25, 2019	Z-2276-2019	—	terminated	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.
Jul 25, 2019	Z-2275-2019	—	terminated	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.
May 6, 2019	Z-1691-2019	—	terminated	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.
Jan 12, 2018	Z-1391-2018	—	terminated	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.
Jun 22, 2017	Z-0726-2018	—	terminated	An image was obtained with over exposure during a Thorax examination using the AEC function.
May 24, 2017	Z-3036-2017	—	terminated	When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Sep 14, 2015	Z-0263-2016	—	terminated	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.