FDA.reportPublic FDA data

Intelli-C Accessory

Primary DI
05713464000459
Brand
Intelli-C Accessory
Company
Nrt - Nordisk Røntgen Teknik A/S
Model
21330018
Device description
A removable table top for the Intelli-C X-ray system, left side suspended. The removable table enables better space for wheelchair patients inside the C-arc as well as stretcher patients.
Published
2019-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173631000Intelli-CNrt X-Ray A/S2018-07-11OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713464000459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713464000459057134640004595713464000459

GMDN Terms#

Term, Definition table
TermDefinition
Operating table top trolleyA component of a modular operating table assembly designed as a lightweight trolley for the transport and transfer of loose operating table tops, with or without the patient, to and from the system's base in the operating room (OR). This trolley (cart) may have a fixed height or be hydraulically height-adjustable by a pump to enable small height adjustments with regards to positioning the table top onto or off the column.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4586283500nrt@nrtxray.com

Regulatory Flags#

DUNS number
307332705
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713464000640Adora Accessory042822002025-09-16
05713464000657Adora Accessory042834002025-09-16
05713464000664Adora Accessory042863902025-09-16
05713464000671Adora Accessory042865002025-09-16
05713464000688Adora Accessory042866002025-09-16
05713464000695Adora Accessory042895002025-09-16
05713464000701Adora Accessory042822402025-09-16
05713464000862Adora DRFi045500102025-09-16
05713464000329Intelli-C Accessory029199002019-01-21
05713464000435Intelli-C Accessory032856002019-05-01
05713464000442Intelli-C Accessory213200182019-05-01
05713464000756Intelli-C Accessory032849002022-05-31
05713464000343Intelli-C Accessory032845002019-01-21
05713464000732Intelli-C Accessory032820002022-04-11
05713464000749Intelli-C Accessory032830002022-04-11
05713464000336Intelli-C Accessory032820002019-01-21
05713464000381Intelli-C Accessory032830002019-02-19
05713464000411Intelli-C Accessory032840502021-04-16
05713464000565Intelli-C Accessory032842002021-04-16
05713464000374Intelli-C Accessory032826002020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHOWB2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHJAA2025-07-30
00850073646007TrackXTrackX Technology, LLCOWB2025-07-24
00850073646014TrackXTrackX Technology, LLCOWB2025-07-24
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
08809244060465GenorayGENORAY CO., LTD.OWB2025-05-02
07613327664089Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWB2025-02-11
00195278685001OECGE Hualun Medical Systems Co., LtdOWB2025-01-09