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

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
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065626069
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842000101239Merge PACS9.52026-05-07
00842000100614RadSuite 8.322019-09-25
00842000100904Merge OrthoTemplates40.2.22023-06-09
00842000100782IBM iConnect Access7.12019-04-30
00842000100713Merge OrthoCase3.7.52018-09-21
00842000100720IBM iConnect Access7.02018-10-26
00842000100683iConnect Access6.52019-05-10
00842000100126Merge iConnect Access6.32016-12-12
00842000100645Merge iConnect Access6.42017-10-17
00842000100041Merge Cardio10.32017-01-12
00842000100416Merge Cardio11.02017-09-05
00842000100591Merge Cardio10.12017-02-10
00842000100874Merge Hemo 10.32020-04-23
00842000101031CADstream6.42021-09-21
00842000100881CADstream6.32021-02-08
00842000100638CADstream6.22019-04-26
00842000100027Merge Hemo9.42021-09-21
00842000100010Merge Hemo10.0.42016-11-30
00842000100034Merge HEMO10.12017-10-19
00842000100430Merge Hemo 10.22019-06-27

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