Sonalleve 451000080786

GUDID 07540281000250

SONALLEVE MR-HIFU V2 INGENIA 1.5T

Profound Medical Inc

Therapeutic oncological/gynaecological ultrasound system
Primary Device ID07540281000250
NIH Device Record Key46f0e202-090f-4f6a-b482-7137a5e60b90
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonalleve
Version Model Number451000080786
Catalog Number451000080786
Company DUNS243898678
Company NameProfound Medical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540281000250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QNDAblation System, High Intensity Focused Ultrasound (Hifu), Mr Guided, Orthopedic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-14
Device Publish Date2025-08-06

On-Brand Devices [Sonalleve]

07540281000267SONALLEVE MR-HIFU V2 INGENIA 3T
07540281000250SONALLEVE MR-HIFU V2 INGENIA 1.5T
07540281000243SONALLEVE MR-HIFU V2 ACHIEVA 3T
07540281000236SONALLEVE MR-HIFU V2 ACHIEVA 1.5T

Trademark Results [Sonalleve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SONALLEVE
SONALLEVE
79083599 4061938 Live/Registered
Profound Medical Inc.
2010-03-25

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.