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

DynaCAD Lung Server

Name: DynaCAD Lung Server
Brand: DynaCAD Lung Server

2.3.0.224889, Release date: 2017-12-13 2.3.1.239548, Release date: 2019-10-01

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

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 DynaCAD Lung Server
Listed by	Mevis Medical Solutions AG, Germany
FDA product code	OEB
Device type	Lung Computed Tomography System, Computer-Aided Detection
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Complaint-file establishment, Manufacturer
510(k)	K043617
Record published	2017-12-21
Record revised	2023-12-04 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, manufacturing date, serial number
Distribution end date	2022-05-01

Catalogue Numbers

Catalogue numbers for DynaCAD Lung Server
Catalogue number	Size	Status
2.3		In distribution
2.2		Withdrawn

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
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
DynaCAD Lung	Mevis Medical Solutions AG	1

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K201501	2021-02-23

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.