Quality Care Suite 5833126

GUDID 00195278584441

Quality Care Suite 2.0, Medical Device

GE MEDICAL SYSTEMS, INC.

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 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: 00195278584441
• NIH Device Record Key: 84b35f44-dffa-4992-9c34-e9f6704ba43f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quality Care Suite
• Version Model Number: 2.0
• Catalog Number: 5833126
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278584441 [Primary]

FDA Product Code

• LHO: Instrument, quality-assurance, radiologic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-01-24

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

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• 00195278584441 - Quality Care Suite: 2023-09-22Quality Care Suite 2.0, Medical Device
• 00195278584441 - Quality Care Suite: 2023-09-22 Quality Care Suite 2.0, Medical Device
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• 00195278630384 - Spectral Color Overlay: 2023-09-04 Spectral Color Overlay MD Application Container for Smart Subscription
• 00195278518866 - Revolution: 2023-04-10 Revolution CT Power - Designated System Medical Device