FDA.reportPublic FDA data

Codonics Horizon® Multi-media Imager

Primary DI
00814905020212
Brand
Codonics Horizon® Multi-media Imager
Company
CODONICS INC.
Model
150C
Device description
Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 150C
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
K021054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021054000CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGERCodonics, Inc.2002-05-09LMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814905020212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814905020212008149050202128149050202120814905020212

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
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60889976559352DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-04-28
04560141932487DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141932494DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141945630DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141945647DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141921641DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141922686DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141923119DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
04560141923126DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
04547410080520FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
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04547410080773FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080797FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410142433FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410142457FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
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
04547410265989FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
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