What is FDA product code NVV?

Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.

Clinical Chemistry › Laboratory InstrumentsDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Imaging System HIS-5000U

Name: Imaging System HIS-5000U
Brand: Imaging System HIS-5000U

imaging system is intended for help observation and recording of eye using a slit lamp

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code NVV
Manufacturer	City	Province	Registered as	Device types
Hangzhou Diagens Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	2

Record

Regulatory record for Imaging System HIS-5000U
Listed by	Huvitz Co., Ltd., South Korea
FDA product code	NVV
Device type	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Device class	Class 1
Regulation	21 CFR 862.2100
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
Record published	2019-05-10
Record revised	2026-04-27 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Imaging System HIS-5000U
Catalogue number	Size	Status
HIS-5000U		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SoftMedia	SCC Soft Computer	14
Sunquest PowerPath	CliniSys, Inc	2
Sunquest CoPathPlus	CliniSys, Inc	2
Ultra Laboratory Information System	Cirdan Imaging Limited	1
Sunquest VUE	CliniSys, Inc	1
Clinisys CoPathPlus	CliniSys, Inc	1
EUROLabOffice 4.0	Euroimmun Medizinische Labordiagnostika AG	1
CyberLAB	Aspyra, LLC.	1
Sentinel	Vistapath Biosystems Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.