FDA.reportPublic FDA data

LIAC HWL

Primary DI
08057014731224
Brand
LIAC HWL
Company
S.I.T. SORDINA IORT TECHNOLOGIES SPA
Model
10 MeV
Catalog number
900091001
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172961000LIAC HWLSit Sordina Iort Technologies Spa2018-06-11IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057014731224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057014731224080570147312248057014731224

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.

Contacts#

Phone, Email table
PhoneEmail
0692062446regulatory@soiort.com

Regulatory Flags#

DUNS number
339852325
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057014731231LIAC HWL12 MeV9000910022026-04-30
08057014730050LIAC10 MeV9000500012016-09-12
08057014730067LIAC12 MeV9000500022016-09-12
08057014730425ABSORBER SHIELDDiameter 50 mmN394050-02-052016-09-12
08057014730432ABSORBER SHIELDDiameter 60 mm N394060-02-052016-09-12
08057014730449ABSORBER SHIELDDiameter 70 mmN394070-02-052016-09-12
08057014730456ABSORBER SHIELDDiameter 80 mmN394080-02-052016-09-12
08057014730463ABSORBER SHIELDDiameter 90 mmN394090-02-052016-09-12
08057014730470ABSORBER SHIELDDiameter 100 mmN394100-02-052016-09-12
08057014730487NOVAC1110 MeVN300000-01-032016-09-12

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Primary DI, Brand, Company table
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