What is FDA product code NQQ?

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

Radiology › DiagnosticSystem, Imaging, Optical Coherence Tomography (Oct)

VivoSight

Name: VivoSight
Brand: VivoSight

The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue…

Registry build 21.09.26

The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient’s clinical conditions.

2manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1).

Chinese manufacturers registered for FDA product code NQQ
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Shenzhen Vivolight Medical Device&Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for VivoSight
Listed by	Michelson Diagnostics Ltd, United Kingdom
FDA product code	NQQ
Device type	System, Imaging, Optical Coherence Tomography (Oct)
Device class	Class 2
Regulation	21 CFR 892.1560
Establishment	Manufacturer
510(k)	K093520
Record published	2016-11-14
Record revised	2023-11-10 (version 5)

Specifications

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

Catalogue Numbers

Catalogue numbers for VivoSight
Catalogue number	Size	Status
VivoSight		In distribution
VivoSight Dx		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Optis™	St. Jude Medical	13
Optis™	Lightlab Imaging, Inc.	11
Luminscan(TM) Disposable Imaging Kit	Micro-Tech (Nanjing) Co., Ltd.	9
Ilumien™	Lightlab Imaging, Inc.	6
Cornaris Intravascular Imaging System	Shenzhen Vivolight Medical Device&Technology Co., Ltd.	2
AptiVue™	Lightlab Imaging, Inc.	2
Pantheris	Avinger, Inc.	2
NvisionVLE Imaging Console	Ninepoint Medical, Inc.	1
NvisionVLE Imaging Console Refurbished	Ninepoint Medical, Inc.	1
NvisionVLE Marking Probe 17mm	Ninepoint Medical, Inc.	1
NvisionVLE Low Profile Imaging Probe, 20mm Working Distance	Ninepoint Medical, Inc.	1
S-Series OCT	Perimeter Medical Imaging AI, Inc.	1

Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K153283	2016-08-11
K093520	2010-01-05

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.