Duns Number:539852079
Device Description: The Geometric Quality Assurance Phantom is intended to provide the operator with spatial r The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric distortions of the MR scanner is acceptable for the intended application.
Catalog Number
-
Brand Name
Geometric QA Phantom
Version/Model Number
459800438932
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
LHO
Product Code Name
Instrument, quality-assurance, radiologic
Public Device Record Key
2a6fc827-a460-47f2-ad39-a6a8f3998484
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |