Codonics Horizon® Operating Software

GUDID 00814905020052

V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C, 54C, and 55C

CODONICS INC.

Diagnostic-imaging multiformat camera

• Primary Device ID: 00814905020052
• NIH Device Record Key: df10733d-9b4a-4e49-b8ab-5d65644681ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Codonics Horizon® Operating Software
• Version Model Number: 3.0.2
• Company DUNS: 101533727
• Company Name: CODONICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814905020052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021054

FDA Product Code

• LMC: Camera, Multi Format, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [Codonics Horizon® Operating Software]

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