FDA.reportPublic FDA data

Delta4 Discover

Primary DI
17350005180062
Brand
Delta4 Discover
Company
Scandidos AB
Model
SDOS105-01
Catalog number
SDOS105-01 (Varian)
Device description
The intended use of the device is• quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking)• quality assurance of the radiation delivery system.
Published
2016-09-25
Public version status
Update
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
K151426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151426000ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+Scandidos AB2016-01-29IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350005180062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1735000518006217350005180062

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Sterilization Methods#

Method table
Method

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
17350005180093Delta4 Phantom+Wired (PW)SDOS101-462019-08-14
17350005180048Delta4 Phantom+ MRPMMASDOS101-362019-04-24
17350005180086Delta4 Phantom+ MRPWSDOS101-342019-04-24
17350005180000Delta4 Phantom+PMMASDOS101-202016-09-25
17350005180017Delta4 Phantom+PWSDOS101-212016-09-25
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
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