Duns Number:413819707
Device Description: "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset."
Catalog Number
989603020982
Brand Name
Ingenia
Version/Model Number
Acoustic Hood
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193215,K213583
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
0b8d1ed9-0bd6-48dd-bdca-7d6d6e16bce0
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 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. | 349 |