FDA.reportPublic FDA data

INTRASKAN DC

Primary DI
D83399927203000
Brand
INTRASKAN DC
Company
ImageWorks
Model
9992720300
Catalog number
9992720300
Device description
INTRASKAN DC FLOOR MOUNT
Published
2017-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103579000INTRA SKAN DCSkanray Technologies2011-03-18EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D83399927203000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, mobileAn x-ray generator with special size, weight, and power requirements that makes it suitable for use in a mobile x-ray system, e.g., a system designed to be pushed or driven to various locations within a facility. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer, inverter, and capacitor discharge generator designs. It typically comprises a control assembly (console) and high voltage transformer assembly or is of a mono-tank generator design. This generator is an integral component of a mobile diagnostic x-ray system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
833648087
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83399924121000EVA SELECT999241210099924121002016-12-02
D83399924121050EVA SELECT999241210599924121052016-12-02
D83399924122000EVA SELECT999241220099924122002016-12-02
D83399924122050EVA SELECT999241220599924122052016-12-02
D83399924131000EVA SELECT DIRECT999241310099924131002017-08-14
D83399924131050EVA SELECT DIRECT999241310599924131052017-08-14
D83399924132000EVA SELECT DIRECT999241320099924132002017-08-14
D83399924132050EVA SELECT DIRECT999241320599924132052017-08-14
D83399924908000EVASOFT999249080099924908002016-12-02
D83399927200000INTRASKAN DC999272000099927200002017-08-15
D83399927201000INTRASKAN DC999272010099927201002017-08-15
D83399927202000INTRASKAN DC999272020099927202002017-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
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