AccessGUDID - DEVICE: CARA (B543CAR0)

GUDID

Device Identifier (DI) Information

Brand Name: CARA
Version or Model: Version 4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diagnos Inc

Primary DI Number: B543CAR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200584196 *Terms of Use

Device Description: CARA is an innovative software program that uses enhanced digital images to support and identify the early detection of vision loss and more specifically diabetic retinopathy. CARA is a teleophthalmology platform which includes advanced retinal imaging technology and clinical grading services by eye care professionals.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60724	Multidisciplinary medical image management software	A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFJ	System, Image Management, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a494cafe-e218-4ae6-bb09-dfd572b78495
Public Version Date: January 10, 2023
Public Version Number: 3
DI Record Publish Date: June 04, 2018