FDA.reportPublic FDA data

OmniTom Elite PCD

Primary DI
10815411020793
Brand
OmniTom Elite PCD
Company
NEUROLOGICA CORP.
Model
0-NL5000-003
Published
2023-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815411020793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081541102079310815411020793

GMDN Terms#

Term, Definition table
TermDefinition
Limited-view-field CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Regulatory Flags#

DUNS number
145008178
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815411020847OmniTom Elite PCD0-NL5100-0012026-03-23
10815411020533BodyTom 640-NL4100-0012023-06-09
10815411020663OmniTom Elite0-NL5000-0022021-11-10
10815411020809OPTION, NL4X00 WS-240V-S0-00132-0022023-08-15
10815411020816OPTION, NL4X00 WS-240V0-00132-0032023-08-15
10815411020823OPTION, NL4X00 WS-120V-S0-00132-0012023-08-15
10815411020595MSU STRETCHER0-00192-0012022-02-09
10815411020670OPTION, STRYKER PROCUITY BED ADAPTER0-00204-0012022-02-08
10815411020182Hill-Rom Advanta 20-00143-0012021-12-06
10815411020472Large Veterinary Platform0-00173-0012021-12-06
10815411020496HillRom Centrella0-00181-0012021-12-06
10815411020502Stryker Spirit 5700 Adapter0-00185-0012021-12-06
10815411020519Arjo Huntleigh Adapter0-00187-0012021-12-06
10815411020526Huntleigh Enterprise Adapter0-00102-0012021-12-06
10815411020540OPTION, STRYKER SECURE ADAPTER0-00019-0012021-12-06
10815411020557OPTION, SILHOUETTE SCANBOARD WITH TARGET0-00135-0022021-12-06
10815411020564OPTION, HILL-ROM PROGRESSA PULMONARY SCANBOARD WITH TARGET0-00139-0022021-12-06
10815411020083Stryker FOB Adapter0-00086-0012021-12-03
10815411020175Hill Rom Bed Adapter0-00142-0012021-12-03
10815411020199Stryker Bed Adapter0-00149-0012021-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12
04987670105579Aquilion ONECANON INC.JAK2025-01-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
17630039302051Remote ControlBracco Injeneering SAJAK2024-05-29
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)Auris Health, Inc.JAK2024-05-05
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
37630039301980IV PoleBracco Injeneering SAJAK2024-03-01