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

SoftMedia

Name: SoftMedia
Brand: SoftMedia

14 catalogue numbers from 3.2.7.310, listed by SCC Soft Computer, United States, under Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

14catalogue numbers in this listing

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 SoftMedia
Listed by	SCC Soft Computer, United States
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	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2019-03-15
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Latex	Labelled latex-free
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for SoftMedia
Catalogue number	Size	Status
3.2.7.310		In distribution
3.2.7.303		In distribution
3.2.7.313		In distribution
3.2.7.305		In distribution
3.2.7.401		In distribution
3.2.7.402		In distribution
3.2.7.309		In distribution
3.2.7.311		In distribution
3.2.7.304		In distribution
3.2.7.306		In distribution
3.2.7.312		In distribution
3.2.7.403		In distribution
3.2.7.308		In distribution
3.2.7.307		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sunquest PowerPath	CliniSys, Inc	2
Sunquest CoPathPlus	CliniSys, Inc	2
Imaging System HIS-5000U	Huvitz Co., Ltd.	1
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.