FDA.reportPublic FDA data

Delta4 Phantom+

Primary DI
17350005180093
Brand
Delta4 Phantom+
Company
Scandidos AB
Model
Wired (PW)
Catalog number
SDOS101-46
Device description
The intended use of the device is• quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking).• quality assurance of the radiation delivery system.
Published
2019-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350005180093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1735000518009317350005180093

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality therapeutic radiation phantom, anthropomorphicA device consisting of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is available in both fixed and variable designs and typically include holders for ionization chambers, dosimeters or radiation measurement instruments. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used for quantitative and subjective assessments of the performance of a radiation therapy treatment planning system (RTTPS) and therapeutic radiation delivery systems.

Contacts#

Phone, Email table
PhoneEmail
+46184723030info@scandidos.com

Regulatory Flags#

DUNS number
507639297
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350005180048Delta4 Phantom+ MRPMMASDOS101-362019-04-24
17350005180086Delta4 Phantom+ MRPWSDOS101-342019-04-24
17350005180000Delta4 Phantom+PMMASDOS101-202016-09-25
17350005180017Delta4 Phantom+PWSDOS101-212016-09-25
17350005180062Delta4 DiscoverSDOS105-01SDOS105-01 (Varian)2016-09-25
17350005180079Delta4 DiscoverElektaSDOS105-022017-12-11
17350005180024Delta4 Phantom+Wired (PMMA)SDOS101-352016-09-25
17350005180031Delta4 Phantom+IMRT (PMMA)SDOS101-302016-09-25
17350005180055HexaMotionSDOS104-05SDOS104-052016-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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