Analogic ImpaCT

GUDID 00814277020155

Analogic ImpaCT 16-slice

ANALOGIC CORPORATION

Full-body CT system

• Primary Device ID: 00814277020155
• NIH Device Record Key: 6eff3f1a-02ee-4a3c-83cf-c50a262fd658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Analogic ImpaCT
• Version Model Number: 10-79182-01
• Company DUNS: 019677418
• Company Name: ANALOGIC CORPORATION
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814277020155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182147

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Analogic ImpaCT ]

• 00814277020308: Analogic ImpaCT 128-slice
• 00814277020162: Analogic ImpaCT 64-slice
• 00814277020155: Analogic ImpaCT 16-slice