FDA.reportPublic FDA data

OPTION, WS CART NL4000

Primary DI
10815411020229
Brand
OPTION, WS CART NL4000
Company
NEUROLOGICA CORP.
Model
0-00132-001
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102677000BODYTOM NL 4000Neurologica Corporation2011-03-24JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815411020229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081541102022910815411020229

GMDN Terms#

Term, Definition table
TermDefinition
CT system workstationA device that is a component of a computed tomography (CT) system and which is designed to receive and transmit data both on-line and off-line. It is typically located at a site remote from the operator's console. It differs from the operator console in that it does not contain the controls for the direct operation of the CT system. It is configured to provide the capability to further process, manipulate and/or view patient images and information collected from the CT system and possibly other related x-ray based imaging systems.

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
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
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