FDA.reportPublic FDA data

HistoSonics

Primary DI
00850006962280
Brand
HistoSonics
Company
Histosonics, Inc.
Model
EDNTH12
Device description
Treatment Head, 12cm
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue AblationGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006962280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006962280008500069622808500069622800850006962280

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth12Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8777400543info@histosonics.com

Regulatory Flags#

DUNS number
028153599
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006962273HistoSonicsEDNTH142026-02-04
00850006962327EdisonEDNTC10012026-02-04
00850006962082EdisonEDNTC10012025-02-21
00850006962099EdisonEDNTH122025-02-21
00850006962105EdisonEDNTH142025-02-21
00850006962068HistoSonicsHISFL10012024-07-29
00850006962075HistoSonicsHISFK20012024-07-29
00850006962129HistoSonicsHISKT20002024-07-29
00850006962006EdisonEDNTC10012023-12-07
00850006962020EdisonEDNTH02122023-12-07
00850006962037EdisonEDNTH08142023-12-07
00850006962044EdisonEDNSA10012023-12-07
00850006962051EdisonEDNCK20012023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006962273HistoSonicsHistosonics, Inc.QGM2026-02-04
00850006962327EdisonHistosonics, Inc.QGM2026-02-04
00850006962082EdisonHistosonics, Inc.QGM2025-02-21
00850006962099EdisonHistosonics, Inc.QGM2025-02-21
00850006962105EdisonHistosonics, Inc.QGM2025-02-21
00850006962006EdisonHistosonics, Inc.QGM2023-12-07
00850006962020EdisonHistosonics, Inc.QGM2023-12-07
00850006962037EdisonHistosonics, Inc.QGM2023-12-07
00850006962044EdisonHistosonics, Inc.QGM2023-12-07
00850006962051EdisonHistosonics, Inc.QGM2023-12-07