iQ Flex 500-MC-074

GUDID G221500MC0740

Mobile X-ray System consisting of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. The iQFlex M is used with a film-cassette or flat-panel detector.

First Source, Inc.

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• Primary Device ID: G221500MC0740
• NIH Device Record Key: 66a307eb-4ed6-4a96-9520-7a6933018261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ Flex
• Version Model Number: M
• Catalog Number: 500-MC-074
• Company DUNS: 010620413
• Company Name: First Source, 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G221500MC0740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221081

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [iQ Flex ]

• G221500MC0740: Mobile X-ray System consisting of a LED display with up and down soft-keys for controlling kV, a
• G221500MC0800: This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down