Duns Number:557804458
Device Description: 2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. Th 2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a CMOS sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W for a mammographic screening. 2430MCA detector is connected by wire to a viewing station via ethernet connection.
Catalog Number
-
Brand Name
2430MCA
Version/Model Number
2430MCA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202902
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
f6e989dd-7960-4c85-99d5-5bf42c7182a6
Public Version Date
July 06, 2021
Public Version Number
1
DI Record Publish Date
June 28, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 110 |