FDA.reportPublic FDA data

CARA

Primary DI
B543CAR0
Brand
CARA
Company
Diagnos Inc
Model
Version 4
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.
Published
2018-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFJSystem, Image Management, OphthalmicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110869000CARADiagnos, Inc.2011-07-14NFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B543CAR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary medical image management softwareA 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). Also referred to as an operating room (OR) integration software, 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.

Regulatory Flags#

DUNS number
200584196
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053677040512iCare ALTIUS CWCENTERVUE SPANFJ2026-04-29
06430078740296Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2026-01-28
08800019600794Huvitz Integrated Image Server HIIS-1Huvitz Co., Ltd.NFJ2025-08-14
06430078740272Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2025-08-07
00850003069357HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069432HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069500HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069517HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069524HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069531HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069548HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069555HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069562HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069579HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069586HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
00850003069593HarmonyTOPCON HEALTHCARE INCNFJ2025-03-04
G20910Continuum PACSIntegrated Ophthalmic Systems, Inc.NFJ2024-08-19
04260648620053AshvinsMedicalCommunications GmbHNFJ2024-07-09
04260648620060Ashvins variant HEYEX 2 / HEYEX PACSMedicalCommunications GmbHNFJ2024-07-09
04260648620077Ashvins variant Ashvins Diagnostic WorkstationMedicalCommunications GmbHNFJ2024-07-09
04260648620084Ashvins variant Ashvins Diagnostic WorkstationMedicalCommunications GmbHNFJ2024-07-09
04049539070302CALLISTO eye SoftwareCarl Zeiss Meditec AGNFJ2024-06-06
G62650OVision Imaging SystemOPHTHALMIC LABS INCNFJ2024-04-11
00732094223910Welch Allyn, Inc.WELCH ALLYN, INC.NFJ2023-08-24
06430078740005Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2023-08-22
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.NFJ2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.NFJ2023-06-12
04987669200773AL-Scan Viewer for NAVIS-EXNIDEK CO.,LTD.NFJ2023-06-12
04987669607350CEM Viewer for NAVIS-EXNIDEK CO.,LTD.NFJ2023-06-12
04049471070330FORUMCarl Zeiss Meditec AGNFJ2023-04-14