Duns Number:421265537
Device Description: The Device is designed to be used in conjunction with MR Scanner to produce diagnostic ima The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
Catalog Number
-
Brand Name
dS TorsoCardiac 1.5T
Version/Model Number
45980168199X
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"
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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
K212864
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
a6f85889-3cfe-4066-8e86-a9b071b897c3
Public Version Date
April 25, 2022
Public Version Number
1
DI Record Publish Date
April 17, 2022
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. | 10 |