Duns Number:713565195
Device Description: The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images.
Catalog Number
-
Brand Name
ASPIRE Cristalle Digital Breast Tomosynthesis Option
Version/Model Number
DR 3500 TOMO KIT V2.0 USA E
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
OTE
Product Code Name
Digital breast tomosynthesis
Public Device Record Key
efd4190e-d1b0-4b15-96e3-1b21f91650b1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |