FDA.reportPublic FDA data

Codonics Horizon® XL Multi-media Imager

Primary DI
00814905020120
Brand
Codonics Horizon® XL Multi-media Imager
Company
CODONICS INC.
Model
XL
Device description
Grayscale/Color Desktop XL Format Film and Paper Diagnostic Imager
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMCCamera, Multi Format, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMCCamera, Multi Format, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060440000CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGERCodonics, Inc.2006-03-16LMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814905020120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814905020120008149050201208149050201200814905020120

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic-imaging multiformat cameraA mains electricity (AC-powered) camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4402431334support@codonics.com

Regulatory Flags#

DUNS number
101533727
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C610i PCS2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C620i PCS2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C630i PCS2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170C700i PCS2026-04-20
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisSWS2026-04-20
00814905021103Codonics Safe Label System®(SLS) 600i Point of Care Station - 170C600i PCS2023-06-08
00814905020298Codonics Virtua® Controller - 73CVirtua - 73C2023-09-27
00814905020304Codonics Virtua® XR Controller - 74CVirtua XR - 74C2023-09-27
00814905020311Codonics Virtua® C Controller - 91CVirtua C -91C2023-09-27
00814905020328Codonics Virtua® Medical Disc PublisherVirtua2023-09-27
00814905020335Codonics Virtua® XR Medical Disc PublisherVirtua XR2023-09-27
00814905020342Codonics Virtua® C Controller - 90CVirtua C -90C2023-09-27
00814905020359Codonics Virtua® C/E Medical Disc PublisherVirtua C/E2023-09-27
00814905020380Codonics Virtua® Controller - 71CVirtua -71C2023-09-27
00814905020397Codonics Virtua® Controller - 75CVirtua -75C2023-09-27
00814905020403Codonics Virtua® XR Controller - 72CVirtua XR - 72C2023-09-27
00814905020410Codonics Virtua® XR Controller - 76CVirtua XR - 76C2023-09-27
00814905020427Codonics Virtua® C Controller - 92CVirtua C -92C2023-09-27
00814905020823Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C550i PCS2018-10-05
00814905021059Codonics DirectVista Thermal Film, 810-DVC810-DVC2021-05-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04560141932487DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
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04560141945630DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
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04547410142433FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
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04547410222494FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222548FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222555FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222562FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222579FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410265965FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
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