FDA.reportPublic FDA data

NAOMI

Primary DI
04582384740025
Brand
NAOMI
Company
RF CO.,LTD.
Model
XM
Device description
Digital Radiography Sensor
Published
2016-09-29
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
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062376000DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMIRf Systems Lab.2006-10-27MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582384740025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582384740025045823847400254582384740025

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging conversion systemAn assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696283634
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582384740018NAOMIXM2016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800018408209EXPD 4343SDRTECH CorporationMQB2026-03-17
08800018408308EXPD 4343DDRTECH CorporationMQB2026-03-17
08800018408407EXPD 3643DDRTECH CorporationMQB2026-03-17
04549292223774CANON INC.CANON INC.MQB2026-02-06
00854344007795Varex Digital Imaging Software, Nexus DR, v4.19VAREX IMAGING CORPORATIONMQB2026-01-16
04719879300130YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300147YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300154YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300161YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
08800069500105BONX805, DIONE-X80 Portable X-ray Imaging Devicebontech IncMQB2025-12-03
00854344007771Varex Digital Imaging Software, Nexus DR, v4.18VAREX IMAGING CORPORATIONMQB2025-11-13
08800069500013BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500020BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500037BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500044BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500051BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500068BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
04547410484786FDR D-EVO III G35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484793FDR D-EVO III G43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484809FDR D-EVO III C35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484816FDR D-EVO III C43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484823FDR D-EVO III C25iFUJIFILM CORPORATIONMQB2025-08-29
04547410511673FDR D-EVO III G80iFUJIFILM CORPORATIONMQB2025-08-29
04547410515176DR-ID 1200MCFUJIFILM CORPORATIONMQB2025-08-29
08800018430002EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430101EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430200EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430309EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430408EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430507EXPD-N seriesDRTECH CorporationMQB2025-06-13