FDA.reportPublic FDA data

MicroThermX Microwave Ablation System

Primary DI
00810563020533
Brand
MicroThermX Microwave Ablation System
Company
Varian Medical Systems, Inc.
Model
MTX-180
Catalog number
MTX-180
Device description
MicroThermX Microwave Ablation System - Mobile Cart
Published
2019-03-27
Public version status
Update
Distribution status
Not 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
00810563020533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810563020533008105630205338105630205330810563020533

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
8774672009customerservice@endocare.com

Regulatory Flags#

DUNS number
118097024
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesGM11013450GM110134502025-05-21
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRGM11012580GM110125802025-05-16
00816389029699Assembly module, CT/ MRGM11012910GM110129102025-05-16
00816389029743Retraction Nut CT/MRGM11012960GM110129602025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorGM11010740GM110107402024-11-19
00850800006074Vitesse5.0Vitesse 5.02024-11-01
00816389020245Crook Prostate Template for 2.0 mm needlesGM11012230GM110122302024-02-19
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointGM11009580GM110095802023-05-05
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointGM11009550GM110095502023-04-28
008105630220322.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
008105630220492.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
008105630220562.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20
008105630220632.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalPC-2.1SL2023-04-20
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmGM11013240GM110132402019-11-06
00816389021242Titanium-Fletcher-Suit-Delclos-style Applicator Set (Flexible Geometry)AL13030001AL130300012016-09-19
00816389021297X-ray marker wire, 160 cm x 0.6, channel 1AL13116000AL131160002016-09-19
00816389021310X-ray marker wire, 160 cm x 0.6, channel 3AL13118000AL131180002016-09-19
00816389021747Central clamping mechanismGM11000860GM110008602016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmGM11000890GM110008902016-09-23
00816389021792Colpostats for 20mm spread, pairGM11000910GM110009102016-09-19

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