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)

S-Series OCT

Name: S-Series OCT
Brand: S-Series OCT

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional,…

Registry build 21.09.26

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 S-Series OCT
Listed by	Perimeter Medical Imaging AI, Inc., Canada
FDA product code	NQQ
Device type	System, Imaging, Optical Coherence Tomography (Oct)
Device class	Class 2
Regulation	21 CFR 892.1560
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K203578
Record published	2021-12-07
Record revised	2023-06-19 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for S-Series OCT
Catalogue number	Size	Status
PMI001OCT21		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 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

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
K203578	2021-02-25

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.