FDA.reportPublic FDA data

NA

Primary DI
04582275250428
Brand
NA
Company
KONAN MEDICAL, INC.
Model
Cellchek
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K081797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081797000IMAGE STORAGE SYSTEM, MODEL KSS-400Konan Medical, Inc.2009-01-22NFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275250428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275250428045822752504284582275250428

GMDN Terms#

Term, Definition table
TermDefinition
Eye anterior segment analyser softwareAn application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the anterior segment of the eye (i.e., cornea, iris, pupil, anterior chamber and lens) performed with an eye anterior segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690768619
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275250671NACellChek 20-1 PLUS2023-09-27
04582275250664NACellChek 20-12022-04-07
04582275250657NACC 20 rc2021-06-25
04582275250626NACellChek 202020-04-02
04582275250107NANSP2016-08-29
04582275250374NANSPC2016-09-23
04582275250404NACD-152016-09-23
04582275250619N/APOM2017-11-27

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