iQ View 200-CA-308

GUDID G221200CA3080

The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.

First Source, Inc.

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• Primary Device ID: G221200CA3080
• NIH Device Record Key: 794cc0f8-74b1-421c-a8b2-b7a0520c555b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ View
• Version Model Number: V5
• Catalog Number: 200-CA-308
• 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: 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
HIBCC	G221200CA3080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203703

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by First Source, Inc.

• G221200CA3080 - iQ View: 2023-06-21The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
• G221200CA3080 - iQ View: 2023-06-21 The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray
• G221500MC0800 - iQ Flex: 2023-06-21 This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an
• G221100DRSTS0 - iQ Panorama: 2023-06-20 A weight bearing stand that will allow a patient to be positioned for various x-ray examinations of spine and lower extremities.
• G221100DRWBS0 - iQ Elevation: 2023-06-20 A weight bearing stand that will allow a patient to be positioned for various U-Arm x-ray examinations of lower extremities.
• G221500MC0740 - iQ Flex: 2023-06-20 Mobile X-ray System consisting of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered