CS Orthodontic Imaging Software 1043272

GUDID 60192156851635

CS Orthodontic Imaging - Main Office

CARESTREAM DENTAL LLC

Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 60192156851635
• NIH Device Record Key: 85078f05-a6c1-4d97-87ca-2ea5b88d61ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS Orthodontic Imaging Software
• Version Model Number: CS Orthodontic Imaging Software
• Catalog Number: 1043272
• Company DUNS: 019796106
• Company Name: CARESTREAM DENTAL LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192156851635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122427

FDA Product Code

• LLZ: System, image processing, 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: 6
• Public Version Date: 2020-02-10
• Device Publish Date: 2018-01-15

On-Brand Devices [CS Orthodontic Imaging Software]

• 60192156851642: CS Orthodontic Imaging Software
• 60192156851635: CS Orthodontic Imaging - Main Office