FDA.reportPublic FDA data

TULSA-PRO

Primary DI
07540281000014
Brand
TULSA-PRO
Company
Profound Medical Inc
Model
PAD-105
Device description
TULSA-PRO System
Published
2019-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLPHigh Intensity Ultrasound System For Prostate Tissue AblationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191200000TULSA-PRO SystemProfound Medical, Inc.2019-08-15PLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540281000014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540281000014075402810000147540281000014

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic oncological/gynaecological ultrasound systemAn assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243898678
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540281000236Sonalleve4510000807664510000807662025-08-06
07540281000243Sonalleve4510000807764510000807762025-08-06
07540281000250Sonalleve4510000807864510000807862025-08-06
07540281000267Sonalleve4510000807964510000807962025-08-06
07540281001738TULSA-PRO1130081130082024-11-07
07540281001721TULSA-PRO1125621125622023-10-24
07540281001615TULSA-PRO1073442022-11-24
07540281001547TULSA-PRO1054852022-11-30
07540281001554TULSA-PRO1054862022-11-30
07540281001561TULSA-PRO1065822022-11-30
07540281001578TULSA-PRO1065832022-11-30
07540281001585TULSA-PRO1067082022-11-30
07540281001592TULSA-PRO1069552022-11-30
07540281001608TULSA-PRO1071892022-11-30
07540281001639TULSA-PRO1044942022-11-30
07540281001646TULSA-PRO1065152022-11-30
07540281001653TULSA-PRO1044912022-11-30
07540281001660TULSA-PRO1065852022-11-30
07540281001677TULSA-PRO1040102022-11-30
07540281001684TULSA-PRO1040112022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661690000267Focal OneEDAP-TMS FRANCEPLP2026-01-26
03661690000342Endorectal ProbeEDAP-TMS FRANCEPLP2026-01-26
07540281001738TULSA-PROProfound Medical IncPLP2024-11-07
07540281001721TULSA-PROProfound Medical IncPLP2023-10-24
07290019402268EXABLATE PROSTATE Treatment master kit for V2.2INSIGHTEC LTDPLP2022-12-15
07540281001547TULSA-PROProfound Medical IncPLP2022-11-30
07540281001554TULSA-PROProfound Medical IncPLP2022-11-30
07540281001561TULSA-PROProfound Medical IncPLP2022-11-30
07540281001578TULSA-PROProfound Medical IncPLP2022-11-30
07540281001585TULSA-PROProfound Medical IncPLP2022-11-30
07540281001592TULSA-PROProfound Medical IncPLP2022-11-30
07540281001608TULSA-PROProfound Medical IncPLP2022-11-30
07540281001639TULSA-PROProfound Medical IncPLP2022-11-30
07540281001646TULSA-PROProfound Medical IncPLP2022-11-30
07540281001653TULSA-PROProfound Medical IncPLP2022-11-30
07540281001660TULSA-PROProfound Medical IncPLP2022-11-30
07540281001677TULSA-PROProfound Medical IncPLP2022-11-30
07540281001684TULSA-PROProfound Medical IncPLP2022-11-30
07540281001691TULSA-PROProfound Medical IncPLP2022-11-30
07540281001615TULSA-PROProfound Medical IncPLP2022-11-24
07540281001370TULSA-PROProfound Medical IncPLP2022-09-23
07540281001400TULSA-PROProfound Medical IncPLP2022-09-23
07540281000816TULSA-PROProfound Medical IncPLP2022-05-26
07540281000823TULSA-PROProfound Medical IncPLP2022-05-26
07540281000830TULSA-PROProfound Medical IncPLP2022-05-26
07540281000847TULSA-PROProfound Medical IncPLP2022-05-26
07540281000908TULSA-PRO Profound Medical IncPLP2022-05-26
07540281001196TULSA-PROProfound Medical IncPLP2022-05-26
07540281001233TULSA-PRO Profound Medical IncPLP2022-05-26
07540281001240TULSA-PROProfound Medical IncPLP2022-05-26