Duns Number:632899233
Device Description: Philips MicroDose Mammography SI L50 is intended to produce radiographic images of the hum Philips MicroDose Mammography SI L50 is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems.
Catalog Number
714048
Brand Name
MicroDose SI
Version/Model Number
L50
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"
Yes
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
4614fee8-ebbd-4191-92cf-e74dfb702ec0
Public Version Date
August 02, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2016
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. | 3 |