FDA.reportPublic FDA data

Adora Accessory

Primary DI
05713464000695
Brand
Adora Accessory
Company
Nrt - Nordisk Røntgen Teknik A/S
Model
04289500
Device description
Patient table support for Patient CPR For the Adora DRFi X-ray system. A table stabilizer intended to give support to the patient table in case of emergency CPR purposes.
Published
2025-09-16
Public version status
New
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242948000Adora DRFi (04550010)Nrt X-Ray A/S2024-12-23JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713464000695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713464000695057134640006955713464000695

GMDN Terms#

Term, Definition table
TermDefinition
Medical table top floor stand, non-poweredA non-powered device designed to support and stabilize from the floor a medical table top [e.g., an operating table top for hand surgery, or a table top for cardiopulmonary resuscitation (CPR)] or table [e.g., base of a traction table]. It may be in the form of a slender vertical telescopic post, a framework or a multi-jointed structure, and is typically used for support of cantilevered table tops or extensions; it is not intended to function as the primary support for the main body of an operating table top (i.e., not an operating table base).

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
05713464000701Adora Accessory042822402025-09-16
05713464000862Adora DRFi045500102025-09-16
05713464000329Intelli-C Accessory029199002019-01-21
05713464000435Intelli-C Accessory032856002019-05-01
05713464000442Intelli-C Accessory213200182019-05-01
05713464000459Intelli-C Accessory213300182019-05-01
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

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Primary DI, Brand, Company table
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00198953052488AlliaGE MEDICAL SYSTEMSJAA2025-12-17
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