Microfocus APA 1000 System

Primary DI
B0634100145
Brand
Microfocus APA 1000 System
Company
Medifocus, Inc.
Model
Original
Device description
Focus Thermotherapy Device
Published
2015-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0634100145PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia systemA mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828790159
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0638808060ProlieveOriginal2015-09-09
B0638808260ProlieveCoude Tip Catheter2015-09-09