Last synced on 23 September 2022 at 11:05 pm

Headframe

Page Type
Product Code
Definition
To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.
Physical State
made of mostly plastic and has an adjustable frame
Technical Method
Uses ultrasound transducers mounted on a headframe to deliver transcranial ultrasound at diagnostic levels.
Target Area
Head
Review Panel
Neurology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OVC is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Headframe

Page Type
Product Code
Definition
To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.
Physical State
made of mostly plastic and has an adjustable frame
Technical Method
Uses ultrasound transducers mounted on a headframe to deliver transcranial ultrasound at diagnostic levels.
Target Area
Head
Review Panel
Neurology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OVC is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.