What is FDA product code OEB?

To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.

Radiology › Image Processing and StorageLung Computed Tomography System, Computer-Aided Detection

Zsquare ENT-Flex Imaging Core

Name: Zsquare ENT-Flex Imaging Core
Brand: Zsquare ENT-Flex Imaging Core

Zsquare ENT-Flex Imaging Core. Reusable. Hand Held. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Console.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code OEB
Manufacturer	City	Province	Registered as	Device types
Beijing Infervision Healthcare Medical Technology Co., Ltd.	Beijing	Beijing	Complaint-file establishment	4

Record

Regulatory record for Zsquare ENT-Flex Imaging Core
Listed by	Zsquare Ltd, Israel
FDA product code	OEB
Device type	Lung Computed Tomography System, Computer-Aided Detection
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Manufacturer
510(k)	K220004
Record published	2023-03-23

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 Zsquare ENT-Flex Imaging Core
Catalogue number	Size	Status
1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ClearRead CT Console	Riverain Technologies	20
ClearRead CT Server	Riverain Technologies	16
ClearRead CT Docker	Riverain Technologies	14
ClearRead CT	Riverain Technologies	11
ClearRead CT Platform Docker	Riverain Technologies	7
Veolity	Mevis Medical Solutions AG	2
Veolity LungCAD	Mevis Medical Solutions AG	2
Visia LungCAD	Mevis Medical Solutions AG	2
DynaCAD Lung Server	Mevis Medical Solutions AG	2
InferRead Lung Ct.ai 2.1.2.1	Infervision US Inc	1
InferRead Lung Ct.ai	Infervision Medical Technology Co., Ltd.	1
Aview Lung Nodule CAD	Coreline Soft Co., Ltd.	1

Showing 12 of 13. All products under Lung Computed Tomography System, Computer-Aided Detection

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.