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)

NvisionVLE Imaging Console Refurbished

Name: NvisionVLE Imaging Console Refurbished
Brand: NvisionVLE Imaging Console Refurbished

Catalogue number 94101-R, listed by Ninepoint Medical, Inc., United States, under System, Imaging, Optical Coherence Tomography (Oct). 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

8510(k) clearances naming this product code

1recall

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 NvisionVLE Imaging Console Refurbished
Listed by	Ninepoint Medical, Inc., United States
FDA product code	NQQ
Device type	System, Imaging, Optical Coherence Tomography (Oct)
Device class	Class 2
Regulation	21 CFR 892.1560
510(k)	K143678
Record published	2016-09-22
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature -20 to 60 °C; Handling environment humidity 15 to 95 % RH

Catalogue Numbers

Catalogue numbers for NvisionVLE Imaging Console Refurbished
Catalogue number	Size	Status
94101-R		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
VivoSight	Michelson Diagnostics Ltd	2
AptiVue™	Lightlab Imaging, Inc.	2
Pantheris	Avinger, Inc.	2
NvisionVLE Imaging Console	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
K191117	2019-07-19
K182616	2018-11-02
K182261	2018-10-16
K153479	2016-02-16
K143678	2015-02-06
K120800	2013-04-25
K121195	2012-07-25
K112770	2011-12-16

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of NvisionVLE Imaging Console Refurbished
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Ninepoint Medical, Inc.	510(k) number	2018-04-11	Class II	Process control	Distal tips of the probes may detach from the probe shaft during use.	152	2018-08-20

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.