Device
iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data,...
Manufacturer
CENTERVUE SPA
CENTERVUE SPA
Model: iCare ALTIUS CW
Catalog: BACW000010
DI: 08053677040512
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
iCare ALTIUS CW is a Medical Device Software indicated for the review, processing and analysis of ophthalmic medical images, for the review of video, clinical and diagnostic data, measurements and reports, generated by ophthalmic medical devices or documentation system through computerized networks, to support trained healthcare professionals in the diagnosis and monitoring of several eye pathologies.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c7130225-2738-4480-9301-8c6ff1b1f5c5
Distribution Status:
In Commercial Distribution
DUNS Number:
338702316
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08053677040512
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44106
Name: Patient health record information system application software
Definition:
An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.
FDA Product Codes
NFJ
System, Image Management, Ophthalmic
Premarket Submissions
Submission Number:
K234076
Supplement Number:
000