FDA.reportPublic FDA data

NAOMI

Primary DI
04582384740018
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
OTC
false
Sterile
false
Single use
false

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
04582384740018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582384740018045823847400184582384740018

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582384740025NAOMIXM2016-09-29

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