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 Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID03760365550004
NIH Device Record Keyf893435f-33fe-4ffa-a11c-728b1f8fa42c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCysware® 4H
Version Model Number1.xx.xxx
Catalog NumberH001-WEB001
Company DUNS271306935
Company NameABYS MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760365550004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-11
Device Publish Date2023-05-03

Devices Manufactured by ABYS MEDICAL

03760365550004 - Cysware® 4H2023-05-11Abys® 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® 4H2023-05-11 Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather
03760365550011 - Cysart® 4H2023-05-11 The Abys® Medical Cysart® 4H mixed reality application is a medical device designed and intended for use in office room and in

Trademark Results [Cysware]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYSWARE
CYSWARE
79286355 not registered Live/Pending
ABYS MEDICAL
2020-03-19

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