EVASOFT 9992490800

GUDID D83399924908000

EVASOFT IMAGING SOFTWARE

ImageWorks

General-purpose dental x-ray system application software

• Primary Device ID: D83399924908000
• NIH Device Record Key: 741009da-cc1b-4432-bbe2-9b9c17d400ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVASOFT
• Version Model Number: 9992490800
• Catalog Number: 9992490800
• Company DUNS: 833648087
• Company Name: ImageWorks
• 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: 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	D83399924908000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123419

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

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: 2016-12-02

Devices Manufactured by ImageWorks

• D83399924121000 - EVA SELECT: 2018-07-06 EVA SELECT SIZE 1 SYSTEM
• D83399924121050 - EVA SELECT: 2018-07-06 EVA SELECT SIZE 1 SENSOR
• D83399924122000 - EVA SELECT: 2018-07-06 EVA SELECT SIZE 2 SYSTEM
• D83399924122050 - EVA SELECT: 2018-07-06 EVA SELECT SIZE 2 SENSOR
• D83399924131000 - EVA SELECT DIRECT: 2018-07-06 EVA SELECT DIRECT SIZE 1 SYSTEM
• D83399924131050 - EVA SELECT DIRECT: 2018-07-06 EVA SELECT DIRECT SIZE 1 SENSOR ONLY
• D83399924132000 - EVA SELECT DIRECT: 2018-07-06 EVA SELECT DIRECT SIZE 2 SYSTEM
• D83399924132050 - EVA SELECT DIRECT: 2018-07-06 EVA SELECT DIRECT SIZE 2 SENSOR ONLY