Cysware® 4H H001-WEB001

GUDID 03760365550004

Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software.

ABYS MEDICAL

Radiology DICOM image processing application software

• Primary Device ID: 03760365550004
• NIH Device Record Key: f893435f-33fe-4ffa-a11c-728b1f8fa42c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cysware® 4H
• Version Model Number: 1.xx.xxx
• Catalog Number: H001-WEB001
• Company DUNS: 271306935
• Company Name: ABYS MEDICAL
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760365550004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221796

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-05-11
• Device Publish Date: 2023-05-03

Devices Manufactured by ABYS MEDICAL

• 03760365550004 - Cysware® 4H: 2023-05-11Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software.
• 03760365550004 - Cysware® 4H: 2023-05-11 Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather
• 03760365550011 - Cysart® 4H: 2023-05-11 The Abys® Medical Cysart® 4H mixed reality application is a medical device designed and intended for use in office room and in