FDA.reportPublic FDA data

HS AMICA

Primary DI
08058983742471
Brand
HS AMICA
Company
H.S. HOSPITAL SERVICE SPA
Model
AMICA-GEN
Catalog number
AGN-3.2
Device description
AMICA-GEN MW GENERATOR 190W
Published
2019-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182605000HS AMICA devices familyH.S Hospital Service S.P.A2019-10-28GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058983742471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058983742471080589837424718058983742471

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.

Contacts#

Phone, Email table
PhoneEmail
+39069201961hs@hshospitalservice.com

Regulatory Flags#

DUNS number
428898555
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033003340073ALM SETALM SET V TYPEALM 200752021-10-04
08033003340127ALM SETALM SET V TYPEALM 20152019-12-18
08033003340172ALM SETALM SET V TYPEALM 21102019-12-18
08033003340240ALM SETALM SET S TYPEALMS 20102016-12-04
08033003340349ALM SETALM SET Z TYPEALMZ 20102023-04-19
08033055143134ALM SETALM SET V TYPEALM 20102019-12-18
08058983746639TRAP EASYTRAP EASYTRAPEASY 08152025-09-23
08033003340806BIOMOLBIOMOLBM 21102025-07-07
08033055140300BIOMOLBIOMOLBM 21152025-07-07
08033003345016PEIT NEEDLEPEIT NEEDLEPEIT21082025-06-12
08033003345054PEIT NEEDLEPEIT NEEDLEPEIT21202025-06-12
08033003345061PEIT NEEDLEPEIT NEEDLEPEIT2120-62025-06-12
08058983746714PEIT NEEDLEPEIT NEEDLEPEIT2108-62025-06-12
08058983746462HS AMICAAMICA-PROBEAPK16200T19V62025-02-14
08058983746479HS AMICAAMICA-PROBEAPK14270T19V562025-02-14
08058983746486HS AMICAAMICA-PROBEAPK14200T19V62025-02-14
08058983746301HS AMICAAMICA-PROBEAPK14400T19V62025-01-28
08033003344682MB SETMB SETMB 22072025-01-09
48033003344680MB SETMB SETMB 22072025-01-09
08033003347683TOP CUTTOP CUT MTOP 1820M2025-01-09

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Primary DI, Brand, Company table
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