Duns Number:689842626
Device Description: The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagnosis (mammo The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used.
Catalog Number
-
Brand Name
RoseM
Version/Model Number
RSM 1824C
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUE
Product Code Name
Full Field Digital,System,X-Ray,Mammographic
Public Device Record Key
77d8be5b-942b-4539-b8b9-6adea03619fd
Public Version Date
May 07, 2019
Public Version Number
6
DI Record Publish Date
August 04, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |