FDA.reportPublic FDA data

OPTION, NL4X00 WS-240V-S

Primary DI
10815411020809
Brand
OPTION, NL4X00 WS-240V-S
Company
NEUROLOGICA CORP.
Model
0-00132-002
Published
2023-08-15
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170238000BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics2017-06-14JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815411020809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081541102080910815411020809

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.

Sterilization Methods#

Method table
Method

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
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
10815411020304Hill-Rom Century Adapter0-00048-0012021-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29