FDA.reportPublic FDA data

Imaging System HIS-5000U

Primary DI
08800019600121
Brand
Imaging System HIS-5000U
Company
Huvitz Co., Ltd.
Model
HIS-5000U
Catalog number
HIS-5000U
Device description
imaging system is intended for help observation and recording of eye using a slit lamp
Published
2019-05-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019600121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019600121088000196001218800019600121

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.

Contacts#

Phone, Email table
PhoneEmail
+82314289100svc@huvitz.com

Regulatory Flags#

DUNS number
688154202
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
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
08800019601081LS-100-TIPLS-100-TIP-3S2026-07-17
08800019601128LSO-100-TIPLSO-100-TIP-NORMAL2026-07-17
08800019601135LSO-100-TIPLSO-100-TIP-SMALL2026-07-17
08800019600954Vision ScreenerHVS-12026-02-13
08800019600992Auto Ref-Topographer HRKT-1HRKT-12026-01-30
08800019601074Visual Acuity Chart System HDC-100HDC-1002025-11-19
08800019601005LilivisLS-100-TIP-3R2025-09-08
08800019600794Huvitz Integrated Image Server HIIS-1HIIS-12025-08-14
08800019600961OCTiX IntraOral ScannerLSO-100Y4XXCL-24-000012024-11-26
00880019600961Lilivis SCAN OPTOMOLSO-100Y4XXCL-24-000012024-11-26
08800019600978Instrument Table CIT-4100CIT-41002024-06-24
08800019600985Instrument Table CIT-4200CIT-42002024-06-24
08800019600893Lilivis Scan LS-100LS-100LS-1002024-05-27
08800019600909Lilivis CAD L-CADL-CADLS-1002024-05-27
08800019600411Applanation Tonometer HT-5000HT-5000HT-50002023-06-12
08800019600787Optical Biometer HBM-1HBM-12023-10-18
08800019600916Digital Refractor HDR-7100PHDR-7100P2023-08-24
08800019600923Auto Ref/Keratometer HRK-8100AHRK-8100A2023-08-24
08800019600435Non-contact Tonometer HNT-1PHNT-1PHNT-1P2023-06-12
08800019600503Ref-Keratometer ERK-9100ERK-9100ERK-91002023-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B236CPP8030Clinisys CoPathPlusCliniSys, IncNVV2026-02-18
00860009458109SentinelVistapath Biosystems, Inc.NVV2023-05-01
B236VUE202210Sunquest VUECliniSys, IncNVV2022-12-19
04049016135210EUROLabOffice 4.0EUROIMMUN Medizinische Labordiagnostika AGNVV2022-12-08
B433CL0CyberLABASPYRA, LLCNVV2022-10-12
B236PWP13000Sunquest PowerPathCliniSys, IncNVV2022-04-14
B236CPP8000Sunquest CoPathPlusCliniSys, IncNVV2022-03-28
00859474006663SoftMediaSCC SOFT COMPUTERNVV2020-12-09
00859474006472SoftMediaSCC SOFT COMPUTERNVV2020-12-04
B236CPP7100Sunquest CoPathPlusCliniSys, IncNVV2020-11-12
B236PWP12000Sunquest PowerPathCliniSys, IncNVV2020-11-12
00859474006465SoftMediaSCC SOFT COMPUTERNVV2020-04-29
00859474006410SoftMediaSCC SOFT COMPUTERNVV2020-01-25
00859474006403SoftMediaSCC SOFT COMPUTERNVV2019-11-12
00859474006373SoftMediaSCC SOFT COMPUTERNVV2019-11-08
05060508820024ULTRA Laboratory Information SystemCIRDAN IMAGING LIMITEDNVV2019-10-08
00859474006366SoftMediaSCC SOFT COMPUTERNVV2019-03-15
00859474006342SoftMediaSCC SOFT COMPUTERNVV2018-12-08
00859474006298SoftMediaSCC SOFT COMPUTERNVV2018-07-21
00859474006250SoftMediaSCC SOFT COMPUTERNVV2018-04-04
00859474006212SoftMediaSCC SOFT COMPUTERNVV2018-01-19
00859474006182SoftMediaSCC SOFT COMPUTERNVV2017-10-26
00859474006144SoftMediaSCC SOFT COMPUTERNVV2017-07-15
00859474006106SoftMediaSCC SOFT COMPUTERNVV2017-05-13