CS Imaging Suite 5943014

GUDID 60192155943010

CS IMAGING CLIENT SERVER SUITE

CARESTREAM DENTAL LLC

General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software

• Primary Device ID: 60192155943010
• NIH Device Record Key: 19dceac6-4027-4741-ab4e-776e78839bfc
• Commercial Distribution Discontinuation: 2020-03-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CS Imaging Suite
• Version Model Number: CS Imaging Suite
• Catalog Number: 5943014
• 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	60192155943010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151837

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: 3
• Public Version Date: 2020-03-20
• Device Publish Date: 2020-02-17

On-Brand Devices [CS Imaging Suite]

• 60192155500671: CS IMAGING 8 SUITE
• 60192155314308: CS Imaging Suite
• 60192155943010: CS IMAGING CLIENT SERVER SUITE