CS OMS Imaging Software 1746841

GUDID 60192156851666

CS OMS Imaging Software

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: 60192156851666
• NIH Device Record Key: 80df7d1c-98ed-4701-b623-a0e1c5271be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS OMS Imaging Software
• Version Model Number: CS OMS Imaging Software
• Catalog Number: 1746841
• 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	60192156851666 [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: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-01-15

On-Brand Devices [CS OMS Imaging Software]

• 60192156851666: CS OMS Imaging Software
• 60192156851659: CS OMS Imaging Software