Codonics Horizon® Operating Software

GUDID 00814905020045

V2.1.3 Operating Software for Codonics Horizon® Imagers serial number prefix 50C, 51C, and 52C

CODONICS INC.

Diagnostic-imaging multiformat camera
Primary Device ID00814905020045
NIH Device Record Key5317e892-3c22-4633-82a3-a2cce6d7e01e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCodonics Horizon® Operating Software
Version Model Number2.1.3
Company DUNS101533727
Company NameCODONICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com
Phone4402431334
Emailsupport@codonics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814905020045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMCCamera, Multi Format, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [Codonics Horizon® Operating Software]

00814905020267V4.2.0 Operating Software for Codonics Horizon® GS/G2/G1 Imagers serial number prefix 150C
00814905020069V4.1.2 Operating Software for Codonics Horizon® GS/G2/G1 Imagers serial number prefix 150C
00814905020052V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C, 54C, and 55C
00814905020045V2.1.3 Operating Software for Codonics Horizon® Imagers serial number prefix 50C, 51C, and 52C

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