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

Sunquest PowerPath

Name: Sunquest PowerPath
Brand: Sunquest PowerPath

The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics,…

Registry build 21.09.26

The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information.

1manufacturer

2catalogue 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 Sunquest PowerPath
Listed by	CliniSys, Inc, 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	Manufacturer
Premarket notification	Exempt
Record published	2022-04-14
Record revised	2023-07-24 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number
Distribution end date	2022-05-04

Catalogue Numbers

Catalogue numbers for Sunquest PowerPath
Catalogue number	Size	Status
13.0		In distribution
12.0		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SoftMedia	SCC Soft Computer	14
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.