InSight 2

GUDID 15420045505896

Hologic, Inc.

Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 15420045505896
• NIH Device Record Key: 092327e4-55a0-4c2c-837d-e3f0205ace46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSight 2
• Version Model Number: InSight 2
• Company DUNS: 153623137
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045505896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051025

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

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: 2018-07-06
• Device Publish Date: 2016-08-23

Devices Manufactured by Hologic, Inc.

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• 15420045511491 - Panther Fusion®: 2024-06-18 Varicella zoster virus (VZV) Probe ASR.
• 15420045512115 - Panther Fusion®: 2024-06-18 Hologic CMV Plasmid Control.
• 15420045512146 - Panther Fusion®: 2024-06-18 Hologic VZV Plasmid Control.
• 15420045513877 - DIGITAL DIAGNOSTICS SYSTEM: 2024-06-17 The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system.
• 15420045513884 - DIGITAL DIAGNOSTICS SYSTEM: 2024-06-17 Computer to operate the Genius™ Digital Imager.