FDA.reportPublic FDA data

KOWA VK-2s

Primary DI
04987646808923
Brand
KOWA VK-2s
Company
KOWA COMPANY,LTD.
Model
VK28K
Device description
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
Published
2019-06-10
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K190056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190056000KOWA VK-2sKowa Co. Ltd. Chofu2019-02-12NFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987646808923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987646808923049876468089234987646808923

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692281073
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987646807575KOWA nonmyd 8K9L61K2016-09-16
04987646810476KOWA SL-19SL192BK/W2024-10-08
04987646810223KOWA SL-19SL191BK/W2023-01-10
04987646810032KOWA SL-19SL191K/W2022-12-07
04987646810049KOWA SL-19SL191K/A2022-12-07
04987646810056KOWA SL-19SL191K/G2022-12-07
04987646810063KOWA SL-19SL191K/P2022-12-07
04987646810070KOWA SL-19SL191K/B2022-12-07
04987646804031KOWA SL-15SL150K2016-09-16
04987646806905KOWA SL-17SL170K/W2016-09-16
04987646806912KOWA SL-17SL170K/A2016-09-16
04987646806929KOWA SL-17SL170K/G2016-09-16
04987646806936KOWA SL-17SL170K/P2016-09-16
04987646809128KOWA nonmyd AFK9L64K2020-01-15
04987646807728KOWA DR-1αDE2K2019-06-10
04987646808930KOWA VK-2sVK28UE2019-06-10
04987646808947KOWA VK-2sVK28U2E2019-06-10
04987646805113KOWA AP-7000FT10K2019-01-08
04987646800583KOWA GENESIS-DfK9L51BK2016-09-16
04987646800606KOWA nonmyd a-DIIIK9L58K2018-02-23

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