← Back to catalogue

Neuro Head coil

FDA UDI

Class III (US FDA UDI)

by Insightec

Identity

Trade Name
Neuro Head coil FDA UDI
Generic Name
Therapeutic oncological/gynaecological ultrasound system FDA UDI
Device Name
single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937) FDA UDI
Model / Reference
Neuro Head coil FDA UDI
Description
single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937) FDA UDI

Identifiers

Catalog Number
ASC002258-AA FDA UDI
Primary DI / UDI-DI
07290015461184 FDA UDI
FDA Product Code
POH FDA UDI
GMDN Term
Therapeutic oncological/gynaecological ultrasound system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Therapeutic oncological/gynaecological ultrasound system

Neuro Head coil by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic oncological/gynaecological ultrasound system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Insightec

Sources (1)

  • FDA UDI e0cedb49-375a-44e2-a2a5-8d07852af879 36 fields · synced May 30, 2026