FDA.reportPublic FDA data

Merge Eye Station

Primary DI
00842000100140
Brand
Merge Eye Station
Company
MERGE HEALTHCARE SOLUTIONS INC.
Model
11.6.1
Published
2016-12-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
NFJSystem, Image Management, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
NFJSystem, Image Management, OphthalmicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913929000DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMOphthalmic Imaging Systems1991-11-27HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842000100140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842000100140008420001001408420001001400842000100140

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
065626069
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842000100928Merge Cardio12.12021-09-21
00842000100850eFilm Workstation4.32021-02-08
00842000100867eFilm Lite4.32021-02-08
00842000100454Merge OrthoPACS7.1.2.12019-05-13
00842000100461Merge Unity Pacs11.02019-05-13
00842000100478Merge PACS7.1.2.12019-05-13
00842000100676Merge OrthoPACS7.22019-05-10
00842000100041Merge Cardio10.32017-01-12
00842000100058Merge Unity PACS11.1.22016-12-19
00842000100072Merge PACS7.1.12017-02-10
00842000100089Merge OrthoPACS7.1.12017-02-10
00842000100096Merge Eye Care PACS5.22016-12-01
00842000100126Merge iConnect Access6.32016-12-12
00842000100133iConnect Enterprise Workflow with Merge PACS1.02017-02-22
00842000100287eFilm Workstation4.22016-12-01
00842000100294eFilm Lite4.22016-12-01
00842000100300eFilm Lite4.2.12017-10-31
00842000100317Merge Eye Care PACS5.32017-08-24
00842000100331Merge Unity PACS11.22017-11-30
00842000100348Merge OrthoPACS6.6.3.22017-02-10

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00857253006033FA ModulePhoenix ClinicalHKI2026-04-03
00857253006071DiffuserPhoenix ClinicalHKI2026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011641RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011924RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011931RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
06430078740296Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2026-01-28
06430046261006Optomed Smartscope FAOptomed OyHKI2025-12-12
06430046260597Smartscope Pro full setOptomed OyHKI2025-11-13
06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONHKI2025-09-11
08800019600794Huvitz Integrated Image Server HIIS-1Huvitz Co., Ltd.NFJ2025-08-14
06430078740272Harmony Referral SystemTopcon Healthcare Solutions EMEA OyNFJ2025-08-07
00860014304507OptainOptain Health, Inc.HKI2025-07-07
00860010658109Fundus PhotoFundus PhotoHKI2025-03-31
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKI2025-03-11
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