FDA.reportPublic FDA data

MicroThermX Microwave Ablation System

Primary DI
00851551005002
Brand
MicroThermX Microwave Ablation System
Company
PERSEON CORPORATION
Model
MTX-180
Catalog number
MTX-180
Device description
MicroThermX Microwave Ablation System - Mobile Cart
Published
2017-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141785000MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIESBsd Medical Corp.2015-03-31NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851551005002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851551005002008515510050028515510050020851551005002

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system generatorA mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the liver, lung, pancreas and kidney.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-15 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-972-5555support@perseonmedical.com

Regulatory Flags#

DUNS number
080414615
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851551005019MicroThermX Microwave Ablation SystemMTX-180-T2MTX-180-T22017-08-19
00851551005064SynchroWave Antenna KitSW-1415SW-14152017-08-19
00851551005071SynchroWave Antenna KitSW-1420SW-14202017-08-19
00851551005088SynchroWave Antenna KitSWST-1415SWST-14152017-08-19
00851551005095SynchroWave Antenna KitSWST-1420SWST-14202017-08-19
00851551005156SynchroWave Antenna KitSW-1425SW-14252017-08-19

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Primary DI, Brand, Company table
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